ANNUAL REPORT 2014. Second AJRR Annual Report on Hip and Knee Arthroplasty Data

ANNUAL REPORT 2014 Second AJRR Annual Report on Hip and Knee Arthroplasty Data

Dedication This second AJRR report is dedicated to the memory of Mark B. Coventry, MD. Dr. Coventry established the world s first and longest-running institutional joint replacement registry. The registry he established at the Mayo Clinic has demonstrated the importance of systematic collection and reporting of joint arthroplasty results. Contents ISSN 2375-9100 (print) ISSN 2375-9119 (online) Executive Summary.................. 2 About AJRR...................... 3 2014 Achievements.................. 5 Overall Results.................... 8 Enrollment................. 8 Submitting s................. 9 Surgeon Participants................ 10 Procedural Data Metrics............... 10 Hip Arthroplasty................... 12 Procedural Data: Hips................ 12 Component Metrics: Hips.............. 14 Revision Data: Hips................. 16 Knee Arthroplasty.................. 17 Procedural Data: Knees............... 17 Component Metrics: Knees.............. 18 Revision Data: Knees................ 21 Level II and III Update and Data Reporting........ 22 Programming, Funding, and Alliances.......... 25 Programing and Funding.............. 25 Strategic Alliances and Affiliations.......... 25 Preliminary 2015 Accomplishments........... 28 Appendices..................... 30 References...................... 38

Foreword Along with all members of the Board of Directors and staff of the American Joint Replacement Registry (AJRR), I am pleased and proud to present this organization s second annual report. AJRR is in a period of incredibly rapid growth and progress. While there is a great deal still to be accomplished, the Registry s foundation is now established and many essential ingredients for success are progressing quickly and effectively. This report includes data collected from 2008 to 2014, but focuses on data from 2012 to 2014. The data are derived from 211,721 hip and knee replacements performed at 236 hospitals. The Registry s growth is reflected in that, as of this writing, 577 hospitals now have AJRR membership (an increase of 38% since 2014) and 336,574 hip and knee replacements have been entered into the Registry (an increase of 59% since 2014). Our ultimate goal is to include in the Registry over 90% of all joint replacements completed each year in the United States. Readers of this report will find valuable descriptive information about patterns of arthroplasty practice in the United States. There is contemporary information about total hip arthroplasty (THA) fixation, femoral head diameter, and bearing surface use. There are details about patterns of posterior stabilized and cruciate retaining total knee arthroplasty (TKA) use, and unicompartmental knee arthroplasty use. Important facts that characterize the demographics and underlying diagnoses of patients treated with hip and knee arthroplasty across the entire spectrum of the population (not just the Medicare population), are included. Several more years of data collection are needed before there is much information on implant survivorship; of course providing these data is a key goal of the Registry. This report does give some insight into patterns of early implant failure and revision burden in the United States actionable information that will grow more robust in the next several years. AJRR is building the physical, intellectual, technologic, and human infrastructure needed to collect and analyze essential data, return them in appropriate form, and provide valuable services to stakeholders. In the past year, AJRR moved into offices in the new AAOS headquarters building. AJRR has built an information technology platform that allows for rapid and reliable data collection from hospitals, and userfriendly reporting of analyzed and collated data back to hospitals. AJRR recently took over management of the California Joint Replacement Registry, a group that has great experience collecting measures of patientreported outcomes. Finally, AJRR sought and received early designation as a Qualified Clinical Data Registry (QCDR), the only registry so designated in orthopaedics and one of only 35 such registries in all of medicine. This designation, along with the acquisition of needed infrastructure, provides Registry members with a seamless method to collect Patient Quality Reporting System (PQRS) for submission to the Centers for Medicare & Medicaid Services (CMS). In addition to the large increase of the number of hospitals reporting data and the quick escalation of the number of joint arthroplasties in the database, in the next year there will be many developments that further enhance AJRR s capability. Implementation of ICD-10 will provide more robust data on laterality and the details of revision surgery. AJRR will complete a library of nearly 100,000 implants that cross references the implants generic characteristics with implant name and number. Soon, a mandated Unique Device Identifier (UDI) also will be available for all implants, which will add greater specificity and accuracy to device identification. AJRR is collaborating with other registries around the world, through the International Society of Arthroplasty Registries (ISAR), to standardize some nomenclature and device designations. AJRR has developed and will roll out platforms that permit routine collection of so-called Level II data (such as medical comorbidities) that allow for risk stratification, and Level III data (patientreported outcome measures). Finally, recently enacted legislation will allow AJRR access to CMS claims data, which will provide immediate longitudinal tracking of all arthroplasty revisions in AJRR Medicare patients, even if they have further surgery outside of hospitals that report to AJRR. This capability will immediately improve information on the performance and survivorship of implants used in the United States. I would like to thank and congratulate the dedicated AJRR staff for the past year s many accomplishments. I would also like to thank the past and current AJRR Board of Directors, my predecessor as Board Chair, William Maloney, MD, and the AJRR Medical Director, David Lewallen, MD, for all they have done to set the Registry on its current trajectory. The Registry is moving quickly to fulfill its promise as well as the needs of our patients, the orthopaedic profession, and the many stakeholders who understand the value of a high-functioning national American joint replacement registry. Daniel J. Berry, MD Chair, AJRR Board of Directors American Joint Replacement Registry 2014 Annual Report 1

Executive Summary The American Joint Replacement Registry (AJRR) continued rapid growth in 2014, nearly doubling enrollment from the prior year to 417 hospitals, with data collected from 236 of those hospitals. As a result of a 164% increase in numbers from the previous year, hip and knee arthroplasty procedures of all types totaled over 210,000 since inception through the end of 2014. These procedures were performed by more than 2,200 surgeons from 45 states and represented the full range of hospital types and sizes. Patients undergoing arthroplasty were more frequently female than male (56.8% of hips, 61.6% of knees), and the mean age of patients undergoing arthroplasty procedures in this U.S. sample was 67.7 years for hip arthroplasty patients and 66.1 for knee arthroplasty patients. These findings demonstrate that nearly half of these operations are performed in individuals under the age of 65 who are not likely represented in Medicare data sets. Rheumatoid arthritis has nearly vanished as an indication for hip and knee arthroplasty in the United States, accounting for less than one half of one percent of these procedures. This undoubtedly relates to the dramatic advances in medical management of rheumatoid arthritis and associated inflammatory arthropathies over the past decade. The data in this large sample of the U.S. surgical experience remain mainly descriptive pending longer term follow-up and survivorship data on implants (as affected by hospital, surgeon, technique, and patient factors) that this developing repository of data will eventually make possible. Meanwhile, meaningful descriptive data are included in this report. For example, the data demonstrate that femoral neck fracture accounts for more than one in 10 hip arthroplasties. Analysis also found that surface replacement arthroplasty, which was once widely performed, has fallen to less than 0.5% of hip procedures and were largely concentrated in just a handful of hospitals and surgeons. Knee arthroplasties were performed almost exclusively for osteoarthritis, almost always involved tricompartmental replacement, and involved the use of highly cross-linked or enhanced polyethylene in the majority of procedures. Posterior stabilized components were used in over half of all knee arthroplasties and cruciate retaining designs were used in nearly a third. Unicompartmental replacements accounted for around one out of 20 primary procedures. The revision burden, which is one measure of the success and long-term durability of these procedures, stood at 10% of all hip arthroplasties performed annually while for knees it was lower at 8.1% of all knee arthroplasties per year. These findings and other information included in this report provide a valuable snapshot of the national experience with hip and knee arthroplasty. This report also provides an information platform that will allow documentation of the high degree of effectiveness and selected problems in the performance of these procedures over the long term. AJRR relocated with AAOS and other specialty societies to Rosemont Center, a new headquarters for orthopaedics. 2 American Joint Replacement Registry 2014 Annual Report

About AJRR The American Joint Replacement Registry is a not-forprofit 501(c)(3) tax-exempt organization for data collection and quality-improvement initiatives for total hip and knee replacements. AJRR is a collaborative effort supported by the American Academy of Orthopaedic Surgeons (AAOS), the American Association of Hip and Knee Surgeons (AAHKS), The Hip Society, The Knee Society, hospitals, commercial health plans, medical device manufacturers, and contributions from individual orthopaedic surgeons. Mission AJRR s mission is to focus on improving care for patients who receive hip and knee replacements. By collecting and reporting data, AJRR provides actionable information to guide physicians and patient decision making to improve care. It empowers health care organizations to enhance the patient experience and benchmark performance; orthopaedic surgeons to reduce complications and revision rates; device manufacturers to strengthen post-market surveillance; and health plans to effectively manage costs. Vision AJRR seeks to become the National Registry for total joint replacement, beginning with capturing 90% of all hip and knee replacements, and to leverage this comprehensive data to enhance orthopaedic quality of care, improve patient outcomes and safety, reduce costs, and advance orthopaedic science and bioengineering. Governance and Structure AJRR is unique compared to other national registries by virtue of its multi-stakeholder support and governance. During the evolution of the U.S. arthroplasty Registry effort, a conscientious decision was made to expand from an orthopaedic surgeon-driven model to a more inclusive model involving all categories of individuals and organizations involved in the delivery of arthroplasty care. As a result, the AJRR Board of Directors is derived not only from orthopaedic surgery societies and associations, but also from organizations that represent medical device manufacturers, hospitals, health plans, and patient advocacy groups. In 2014, AJRR had a 13-member Board of Directors, which meets formally in person three times a year. The Board is responsible for AJRR s strategic direction and for oversight of its activities and operations. Initial financial support for the formation of AJRR was provided by AAOS. After formalization of the multistakeholder model, AJRR evolved to include varying levels of financial support from virtually all of the participating stakeholder groups, with the exception of the public. AJRR is evolving toward an organization largely supported by subscriptions or software licensing fees, currently paid by a subset of hospitals desiring on-demand access and display of their own data benchmarked to the national sample. The AJRR platform will soon expand to include practice groups and individual surgeons interested in similar data. Presently, AJRR is financially supported by AAOS, AAHKS, The Hip Society, The Knee Society, hospitals, and medical device manufacturers (via the Advanced Medical Technology Association AdvaMed). The 2014 industry contributors included Biomet, DePuy Synthes, Inc., DJO Surgical, Exactech, MicroPort Orthopedics, Smith & Nephew, Stryker Corporation, and Zimmer. AJRR Board of Directors In 2014, the AJRR Chair of the Board of Directors was William J. Maloney, MD, Elsbach-Richards Professor in Surgery and Chairman of the Department of Orthopaedic Surgery at Stanford University School of Medicine. Dr. Maloney represented AAOS. The Executive Committee was comprised of Dr. Maloney; Vice Chair Daniel J. Berry, MD, of Mayo Clinic; Secretary/Treasurer Steven H. Stern, MD, MBA, of United Healthcare; and Eric Rugo, MBA, of Stryker Corporation. The following were the 2014 AJRR Board of Directors: AAOS Representatives: Gregory B. Krivchenia II, MD, First Settlement Orthopaedics William J. Maloney, MD, Stanford University E. Anthony Rankin, MD, Providence Scott M. Sporer, MD, Midwest Orthopaedics at Rush and Central DuPage Orthopaedic Specialty Society Representatives: Daniel J. Berry, MD, Mayo Clinic (The Hip Society) Terence J. Gioe, MD, University of Minnesota (The Knee Society) Bryan D. Springer, MD, OrthoCarolina (AAHKS) Advanced Medical Technology Association Representatives: Pamela L. Plouhar, PhD, DePuy Synthes, Inc. Eric Rugo, MBA, Stryker Corporation America s Health Insurance Plans Representatives: Robert L. Krebbs, Anthem, Inc. Steven H. Stern, MD, MBA, United Healthcare, Inc. American Association Representative: Kristen Murtos, MBA, Skokie Public Representative: Colin Nelson, Informed Medical Decisions Foundation American Joint Replacement Registry 2014 Annual Report 3

At the conclusion of 2014, Drs. Maloney, Gioe, Stern, and Mr. Rugo all completed their terms of service on the AJRR Board and rotated off. Their many collective years of service are greatly appreciated. AJRR is especially grateful to Dr. Maloney whose work to initiate and then support the effort for a National Arthroplasty Registry dates back nearly 15 years. Public Advisory Board AJRR also has a Public Advisory Board (PAB). This group was established at AJRR s inception to provide direct input to the AJRR Board from both the patient and the public perspective. They have been integral to AJRR s success thus far, ensuring that there is a public voice in the Registry s governance, deliberations, data collection, reporting, and decision making. The PAB members are drawn from a wide variety of public advocacy groups and members of the public who have had joint arthroplasties themselves. In 2014, the Chair of the Public Advisory Board was Colin Nelson. Mr. Nelson is Senior Research Associate at the Informed Medical Decisions Foundation, where he oversees a portfolio of shared decision-making programs in orthopaedics and spine care. Other 2014 PAB members were as follows: John A. Canning, Jr., Chairman, Madison Dearborn Partners, LLC Sally B. Hurme, JD, Project Advisor, Education & Outreach, AARP David G. Mekemson, Patient Representative Martha Nolan, JD, Vice President, Public Policy, Society for Women s Health Research Margaret VanAmringe, MHS, Vice President for Public Policy and Government Relations, The Joint Commission Robert P. Watkins, Esq., Patient Representative Patience White, MD, MA, Co-Director, Got Transition: The Center for Health Care Transition Improvement; Professor of Medicine and Pediatrics George Washington University School of Medicine and Health Sciences AJRR Commission Established in 2014, the AJRR Commission is a group of surgeons without relevant financial conflicts who serve as independent reviewers of the data published in this AJRR Annual Report. The Commission made the final recommendation to the AJRR Board of Directors regarding the content of the Annual Report. The Commission members are known only to the AJRR Board of Directors to ensure members independence and allow them to avoid undue outside influence pertaining to the report. AJRR Committees Besides the Executive Committee, AJRR has three standing committees, each of which is described below. Full membership can be found in Appendix A. The Data Management Committee is responsible for recommendations to the Board concerning data elements to be included in AJRR and the methods by which the selected data are analyzed and reported. The committee is responsible for recommendations concerning proposed research projects. Annually, the committee submits a report to the AJRR Commission to validate the findings of the Data Management Committee. Chair: Daniel J. Berry, MD The Finance and Compensation Committee s responsibility is to review monthly statements and reports in order to keep the AJRR Board abreast of spending and incoming funding and contributions from outside stakeholders and the public. Annually, the committee makes a recommendation to the Board of Directors on staff salaries and benefits. Chair: Steven H. Stern, MD, MBA The Regulatory Committee is a group of sound professionals who monitor and respond to the influencers of the socioeconomic and legislative issues. This committee reports to the Board on governmental opportunities and obstacles affecting the development of AJRR. Co-Chairs: Kevin J. Bozic, MD, MBA and E. Anthony Rankin, MD 2014 AJRR Staff Jeffrey P. Knezovich, CAE, Executive Director David G. Lewallen, MD, Medical Director Kristine F. Baldwin, MS, Data Submission Analyst Lori Boukas, MS, Director of Marketing and Communications September R. Cahue, MPH, Senior Registry Analyst Caryn D. Etkin, PhD, MPH, Director of Analytics Steve Hamada, Senior Software Engineer Randolph R. Meinzer, Director of Information Technology Terra M. Miller, MS, Program Coordinator Matthew E. Timmers, Program Coordinator Hannelore Venable, Administrative Assistant Kate K. Witherspoon, MPA, Program Coordinator 4 American Joint Replacement Registry 2014 Annual Report

2014 Achievements Added 193 hospitals for a total of 417 participants for an 86% increase over 2013 enrollment covered all 50 states Over 210,000 procedures received Data as shown reflect 236 hospitals and 2,247 surgeons Designated a QCDR by CMS allowing for submission of PQRS data Demand Reporting & Electronic Dashboard System released through a subscription-based model Completed collaborative effort with Avalere Health, LLC to conduct AJRR business review Developed a Marketing and Communications Department to expand outreach efforts and strategy AJRR hired a Director and two additional Program Coordinators for a total of four full-time staff who implemented a comprehensive marketing, communication, recruiting, and retention strategy Additional personnel hired for a total of 12 staff members Conducted Level II and Level III pilot program with 20 hospitals Data collected on 8,126 procedures Hosted Worldwide Orthopaedic Arthroplasty Registries session at the AAOS Annual Meeting in New Orleans Published first AJRR Annual Report, which reflects 80,227 procedures Information Technology The AJRR Information Technology (IT) team achieved several milestones in 2014. The first was the addition of electronic reporting of procedural summary metrics via both demand reports and electronic dashboards. The Registry technology was expanded to enable collection of 11 patient-reported outcome measures (PROMs) for both quality of life and functional assessment. As a result of AJRR s continued success in recruiting participating hospitals, AJRR expanded the IT Department by hiring a Data Analyst charged with interfacing with hospital IT and clinical staff facilitating timely electronic submission of Registry data. Electronic submission via data extraction from Electronic Medical Record (EMR) systems minimizes both the manual effort of duplicating information into the AJRR technology system and errors associated with duplicative data entry. As in the past, hospitals are submitting Level I data in two ways. With the first method, hospital staff enters data manually into the system using secure web forms. The second method, electronically extracting Level I data and submitting the data directly to the AJRR data system, is used by approximately 98% of participating AJRR hospitals. The AJRR IT department has also expanded the data-reporting capabilities of the Registry technology to accept Level II and Level III data consistent with methods utilized to collect AJRR Level I data (see Appendix B). To facilitate electronic data transfers, the AJRR has established relationships and business agreements with orthopaedic charting and EMR vendors. Vendor agreements or pre-defined AJRR reports from EMR vendors relieve the burden of creating custom reports AJRR Milestones 2014 >150K QCDR At the Close of 2014, AJRR had 417 Participants Representing ALL 50 States Over 150,000 Procedures Received First Data Audit Completed Designated a Qualified Clinical Data Registry (QCDR) by CMS First Annual Report Completed That Reflects 80,227 Procedures American Joint Replacement Registry 2014 Annual Report 5

on AJRR s behalf. AJRR currently has agreements with eight orthopaedic charting vendors: InVivoLink, Inc.; Ortech, Inc.; URS-Oberd, Inc.; OrthoSensor, Inc.; PA & Associates Healthcare, LLC; Arthrex; MedTrak, Inc.; and Stryker Performance Solutions. These vendors submit data directly to AJRR on behalf of a participating hospital. AJRR IT staff has also been working with Epic and Cerner on predefined AJRR reporting modules. Epic released an AJRR reporting module that functions with their latest EMR and OpTime Operating Room Management System software release. Cerner released a similar reporting module in 2014 in conjunction with their SurgiNet system. AJRR technology staff continues to pursue similar partnerships with other EMR vendors with a goal of eliminating independent IT efforts for our current and future hospital participants. Patient-Specific Risk Calculator In late 2013, a Total Joint Replacement Risk Calculator developed by Ortho Apps, through a collaboration by Massachusetts General, Mayo Clinic, and University of California, San Francisco was donated to AJRR. The calculator is intended to help surgeons assess patient risk for periprosthetic joint infection within two years and 90 day mortality in relation to their comorbidities. The risk tables were generated utilizing several years of CMS data. The risk calculator is now available for surgeons to use free of charge on the AJRR website at www.ajrr.net (on the quality initiatives page). Data Completeness and Quality Monitoring The AJRR data systems verify incoming data by checking conformance to rules contained in the data system. AJRR staff continues to interact individually with hospitals to ensure that all submitting sites conform to AJRR specifications. The IT staff has been verifying the content of hospital data since inception. The submission process includes a test submission, data review, and timely feedback to participating sites in an effort to remove possible sources of error prior to submission of patient information. AJRR continues to work with all submitting sites on data content improvements in the areas of component catalog and lot numbers, formatting of International Classification of Diseases, Ninth Revision (ICD-9) codes, and other improvements to minimize errors reported to the Registry. AJRR is in the process of implementing International Classification of Diseases, Tenth Revision (ICD-10) codes into the system. It is expected the system will be fully operational once the ICD-10 transition is complete. AJRR will provide all participants with ICD-10-Procedure Coding System (PCS) guidance on which procedure codes trigger submission to the Registry, including a crosswalk from ICD-9 to ICD-10-PCS. Patient-Specific Risk Calculator on AJRR s website. 6 American Joint Replacement Registry 2014 Annual Report

Component Reference Database and Component Analysis In 2014, AJRR added approximately 30,000 components to the AJRR reference data system, which expanded the database to over 65,000 orthopaedic implant components. This reference set is based on components submitted over the lifetime of the Registry. Each reference component includes the manufacturer, catalog number, family name, and component type, such as femoral stem or acetabular cup. AJRR continues to work with the AdvaMed Orthopaedic Sector, the International Consortium of Orthopaedic Registries (ICOR), the ISAR, along with the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the National Joint Registry (NJR) for England, Wales, Northern Ireland, and the Isle of Man to harmonize the component definitions, attributes, and detailed data providing a consistent framework for future component analysis requested by the AJRR stakeholders. Orthopaedic Network News continued to support AJRR by providing staff access to component information via its web-based tools. AJRR will complete database infrastructure changes in 2015 that focus on expanding the individual component attributes. Audit of Registry Data AJRR contracted with West Virginia Medical Institute (WVMI) to audit a sample of 2014 data. WVMI has a long history of collaboration with not-for-profit medical organizations, with a specific focus on validating Registry and health record data. In the spring of 2015, WVMI began an audit of N=12 (5%) hospitals that submitted 2014 data to AJRR. WVMI and AJRR undertook an effort to obtain 40 procedure files from 12 randomly selected hospitals (which reflected at least 80% power). The hospitals represented urban, rural, small, and large locations. The audit reviewed two aspects of data submission: (1) among a random sample of 40 procedures, to ensure that data submitted to AJRR correctly reflected the data in the hospital medical records; and (2) among data submitted to AJRR for a given month, to ensure that AJRR received all procedures performed at that hospital (i.e., review of cherry picking ). The audit project was completed in early August 2015. In summary, the overall audit agreement rate for the medical record review was 91.5%. This compares to and is consistent with the score of 92.3% from the audit of 2013 data. Also consistent with last year s audit, the primary errors seen in the medical records were in the variables ethnicity and race, which are optional fields. Many hospitals were unable to submit ethnicity data to WVMI as this data element is not always included in the standard medical record format. The low agreement rate in race was primarily due to hospitals not submitting this data field to AJRR because it is an optional data element, although available in the medical records. Therefore, these data elements were removed from the final score seen above. Other problematic variables included implant catalog and lot numbers and the primary ICD-9 diagnosis code. medical records often do not have a streamlined way to capture catalog and lot numbers via one system to submit to WVMI (i.e., with no lot numbers in the EMR, hospitals did not provide any lot numbers to WVMI). s submit implant data to AJRR many times via manual extraction or query of multiple systems. Multiple ICD-9 diagnosis codes may be utilized for a total joint procedure. The primary ICD-9 diagnosis codes that hospitals submitted to AJRR were appropriate for the specific total joint procedure. However, the diagnosis code submitted to AJRR was listed as a secondary (not the primary) diagnosis code in the medical records. The overall record completeness assessment rate was 85.3%, up from 77.6% last year. AJRR submitted 686 unique records and hospitals submitted a total of 804 records, meaning 118 records were not in the Registry. Sixty-six records were not in the AJRR database, while 52 records had one or more accuracy issues preventing them from matching with the Registry. There were no similarities or trends observed to suggest a reason for these records not having been submitted to AJRR. Likewise, there were no anomalous observations to suggest any cherry picking of records for nonsubmission on the part of hospitals. After examination of the files, it was determined that mismatches were generally due to differences in primary procedure code and primary diagnosis code. American Joint Replacement Registry 2014 Annual Report 7

Overall Results Enrollment A primary focus in 2014 was to increase the number of hospitals that participate in the Registry. Three staff members were dedicated to enroll new facilities and ensure that data were submitted in a timely fashion. As of December 31, 2014, enrollment stood at 417 hospitals, representing all 50 states (see Figures 1 and 2 and Appendix C). This was an increase of 193 hospitals over 2013. More than 25 hospitals in both California and Ohio participated while eight other states had 16-24 hospitals. Figure 1: Enrollment 2012-2014 450 417 400 383 350 Number of s 300 250 200 150 122 158 177 219 242 269 292 100 56 79 50 6 15 26 0 2011 January 2012 April July October January 2013 April July October January 2014 April July October December 2014 Figure 2: 2014 Geographic Distribution of AJRR Participating s (N=417) WASHINGTON OREGON IDAHO MONTANA WYOMING NORTH DAKOTA SOUTH DAKOTA MINNESOTA WISCONSIN MICHIGAN MAINE VT NH MASS NEW YORK CONN RHODE ISLAND CALIFORNIA NEVADA UTAH ARIZONA COLORADO NEW MEXICO NEBRASKA KANSAS OKLAHOMA IOWA PENNSYLVANIA OHIO ILLINOIS INDIANA WEST VIRGINIA MISSOURI VIRGINIA KENTUCKY NORTH CAROLINA TENNESSEE ARKANSAS SOUTH CAROLINA NEW JERSEY DELAWARE MARYLAND WASHINGTON D.C. MISSISSIPPI GEORGIA ALABAMA TEXAS LOUISIANA FLORIDA 1-5 s ALASKA 6-15 16-24 s 25+ s HAWAII 8 American Joint Replacement Registry 2014 Annual Report

Submitting s While delays have continued from the time of hospital enrollment to actual data submission, many hospitals submit archival data from prior months or even years, which ultimately compensates in part for these delays. By the end of 2014, 236 hospitals were submitting data out of a total of 417 hospitals enrolled by that date (Figure 3). This represents nearly a threefold increase from two years before, due not only to increases in the numbers of hospitals enrolled but also to a decrease in the percentage of hospitals enrolled but not yet submitting data. Figure 3: Number of s Submitting Data by Year Number of s 250 200 150 100 50 0 3 4 11 2008 2009 2010 2011 2012 2013 2014 * Data from 2014 included one private practice data submission with 10 procedures (October December 2014) and one Ambulatory Surgery Center (ASC) with 263 procedures. As seen in Figures 4 and 5, arthroplasty procedures in the system are disproportionately performed in largeto medium-sized hospitals and teaching facilities when compared to smaller community based non-teaching facilities. Some small hospitals may not be performing elective hip and knee arthroplasty at all. Thus, the distribution of hospitals submitting data to AJRR, while spanning the full range of hospital sizes and types, is somewhat weighted toward larger sized academic and teaching facilities when compared to American Association (AHA) data on the profile of all hospitals nationally. The following figures describe the characteristics of the hospitals submitting data to AJRR. Please note some data were not available for submitting hospitals. 25 82 159 236* Figure 4: Teaching Affiliation of Submitting s (N=233)* Major Teaching n=49 (21.0%) Minor Teaching n=83 (35.6%) Non-Teaching n=101 (43.3%) Source: FY2013 AHA Annual Survey Database * Not all submitting hospitals had relevant data in the AHA survey Major Teaching s: those with Council of Teaching s designation (COTH) Minor Teaching s: those approved to participate in residency and/or internship training by the Accreditation Council for Graduate Medical Education (ACGME), or American Osteopathic Association (AOA); or those with medical school affiliation reported to the American Medical Association Non-Teaching s: those without COTH, ACGME, AOA, or Medical School (AMA) affiliation Figure 5: Size (Bed Count) of Submitting s (n=246)* Small n=52 (21.1%) Medium n=118 (48.0%) Large n=76 (30.9%) Source: FY2013 AHA Annual Survey Database * Includes some hospitals that submitted in previous years but not in 2014 Small = 1-99 beds; Medium = 100-399 beds; Large = 400+ beds American Joint Replacement Registry 2014 Annual Report 9

Surgeon Participants By the end of 2014, AJRR had collected data on arthroplasty procedures performed by more than 2,200 surgeons (Figure 6). AJRR hospitals report data for an average of 10.0 surgeons (range 1-32). These numbers include surgeons conducting only occasional hemiarthroplasty for hip fracture. Participating hospitals are expected to submit data from all surgeons performing joint arthroplasty at their facility, and tend to do so reliably based on audit data from the past two years. For 2014, the year with the most data, the average number of arthroplasties reported to the Registry for an individual surgeon was 52.3 per year. Table 1 demonstrates an average of 23.2 per year for primary hip arthroplasty (range 1-317) and 39.9 per year for primary knee arthroplasty (range 1-522). Numbers from 2014 reveal that revisions per surgeon were much lower at 6.1 per year for hip revision (range 1-76) and 5.9 per year for knee revision (range 1-103). Actual totals may be higher for some surgeons who operate at both an AJRR participating and non-participating hospital during the same year. Figure 6: Total Number of Surgeons Submitting Data by Year Number of Surgeons 2,500 2,000 1,500 1,000 500 0 22 28 108 192 699 1,477 2,247 2008 2009 2010 2011 2012 2013 2014 Table 1: 2014 Average Procedural Volume for Participating Surgeons (N=2,247) Total Surgeons Total Procedures Per Surgeon Average Range Number of Surgeons Who Submitted Only One Procedure HIP Primary 1,822 42,249 23.2 1-317 295 Revision 757 4,624 6.1 1-76 229 KNEE Primary 1,617 64,552 39.9 1-522 182 Revision 1,045 6,143 5.9 1-103 308 Procedural Data Metrics At the close of 2014, AJRR had received data on over 225,000 procedures going back to 2008 (Figure 7). Of this total 13,822 were from procedures prior to 2012. More than 200,000 have been added since then due to the exponential growth in procedural totals recorded since inception, with an over twofold increase year over year from 2012 onward. Figure 7: AJRR Cumulative Procedural Volume Number of Procedures 250,000 200,000 150,000 100,000 50,000 0 1,326 2,833 6,730 13,822 45,750 107,975 225,543 2008 2009 2010 2011 2012 2013 2014 The data included for analysis reflect cumulative data submitted between 2012 and 2014 only, unless otherwise noted. Due to the small number of hospitals and surgeons submitting data prior to 2012, data from these earlier years could be skewed by sampling error especially with regard to descriptive summaries of hospital, patient, or implant characteristics and therefore was not included in those analyses. Data presented in this Annual Report reflect N=211,721 procedures performed between 2012 and 2014, with the distribution of 60.9% knee procedures and 39.1% hip procedures. Patients included had a mean age of 66.5 years (Standard Deviation (SD) = 11.4) and were approximately 40.3% male and 59.7% female (Figures 8 11). The data in Figure 12 show the distribution of the major procedures (N=211,721) in AJRR s database. Includes 0.5% data entry and analysis error rate The data in Figures 8 and 9 come from N=236 contributing hospitals, one private practice, and one ASC. As expected, the distribution of hip and knee procedures approximates the national distribution as reported by the Centers for Disease Control and Prevention. (www.cdc.gov/nchs/fastats/inpatientsurgery.htm). 10 American Joint Replacement Registry 2014 Annual Report

Figures 8 and 9: Distribution of Hip and Knee Procedures and Gender Distribution of AJRR Procedures (N=211,721) Hip - Knee Knee n=128,880 (60.9%) Hip n=82,841 (39.1%) Gender Male n=85,315 (40.3%) Female n=126,406 (59.7%) Figures 10 and 11: Distribution of Total Sample by Joint Type and Gender (N=211,721) Hip (n=82,841) Knee (n=128,880) Revision Burden Revision burden is the number of revision arthroplasties performed during a year compared to the total number of arthroplasties performed that same year. While there is a relatively small number of early revision procedures within the first months post surgery that are revised the same year, most of the revisions reported in a single year involved arthroplasties placed in prior years. Nonetheless, revision burden can be tracked as a rough indicator of the procedure s overall success over time, and certainly serves as a relative measure of resources required because revision procedures are quite costly compared to primary procedures. In 2014 there was a total of n=8,257 hip revisions out of a total of 82,841 hip arthroplasty procedures of all types. This translates to an overall revision burden of 10.0% for hips. For knee arthroplasties, there were 10,420 revision procedures out of the total of 128,880 knee arthroplasties recorded, for a revision burden of 8.1% for knees. While there was slight variability from year to year, these numbers were relatively constant for hips (9.9% to 10.2%) with minor variation for knees (7.2% to 8.7%). Primary hip procedures include the following ICD-9 procedure codes: 00.85 Resurfacing hip, total, acetabulum, and femoral head; 00.86 Resurfacing hip, partial, femoral head; 00.87 Resurfacing hip, partial, acetabulum; 81.51 Total hip replacement; and 81.52 Partial hip replacement. Male n=35,822 (43.2%) Female n=47,019 (56.8%) Male n=49,493 (38.4%) Female n=79,387 (61.6%) Figure 12: Distribution of Procedures (N=211,721) Primary Knee n=118,460 (56.0%) Primary Hip n=73,837 (34.9%) Revision Knee n=10,420 (4.9%) Revision Hip n=8,257 (3.9%) Hip Resurfacing n=747 (0.4%) Hip revisions include the following ICD-9 procedure codes: 00.70 Revision of hip replacement, both acetabular and femoral components; 00.71 Revision of hip replacement, acetabular component; 00.72 - Revision of hip replacement, femoral component; 00.73 Revision of hip replacement, acetabular liner and/or femoral head only; 00.74 Hip-bearing surface, metal-on-polyethylene; 81.53 Revision of hip replacement, not otherwise specified. Primary knee procedures include the following ICD-9 procedure code: 81.54 Total knee replacement. Knee revisions include the following ICD-9 procedure codes: 00.80 Revision of knee replacement, total (all components); 00.81 Revision of knee replacement, tibial component; 00.82 Revision of knee replacement, femoral component; 00.83 Revision of knee replacement, patellar component; 00.84 Revision of total knee replacement, tibial insert (liner); 81.47 Other repair of knee; 81.55 Revision of knee replacement, not otherwise specified. American Joint Replacement Registry 2014 Annual Report 11

Hip Arthroplasty Procedural Data: Hips The mean age of hip arthroplasty patients was 67.0 years (SD 12.7), which is a slight decrease from last year s mean age of 67.6 years (Figure 13). It will be interesting in the years ahead to see if this small change over successive years remains consistent with the gradual decrease in mean age for hip arthroplasty reported by others over the past four decades 1. _ x = 67.6, SD = 12.8 Figure 13: Age Distribution of Hip Arthroplasty Procedures (N=82,841) 3,500 3,000 2,500 2,000 1,500 1,000 500 0 18 20 22 24 26 Number of Hip Arthroplasty Procedures 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 102 Age of Patient Osteoarthritis was the diagnosis at the time of surgery for more than three out of four patients undergoing hip arthroplasty (Figure 14). Fractured femoral neck was the next most common, accounting for one in 10 arthroplasties performed. Rheumatoid arthritis, a very common diagnosis for THA in the past, now accounts for a mere fraction of one percent of these procedures 2 5. This is undoubtedly due to the dramatic effect newer medical options including diseasemodifying drugs have had on preserving joint function in the rheumatoid patient 2,6. Please note that the number of diagnosis codes does not equal the number of procedure codes because data may reflect a diagnosis code that does not match the procedure code (e.g., hip diagnosis for knee procedure). If that occurs but the components match the procedure code, AJRR does not count the diagnosis code. 12 American Joint Replacement Registry 2014 Annual Report

Figure 14: ICD-9 Diagnosis Codes for All Hip Arthroplasty Procedures (N=74,584) Figure 16: Hip Resurfacing As a Percentage of All Hip Arthroplasty Procedures by Year (N=747) 715: Osteoarthritis n=58,477 (78.4%) 820: Fracture of neck of femur n=7,947 (10.7%) Other n=4,009 (5.4%) 733.42: Avascular necrosis n=2,504 (3.4%) 996: Complications n=1,467 (2.0%) 714: Rheumatoid arthritis n=180 (0.2%) Other codes include those in categories 716, 719, 733, 736, 755. See Appendix D for complete list of diagnosis codes included in each category. Percent of All Hip Arthroplasty 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% 2.0% 1.1% n=376 0.6% n=109 n=262 2012 2013 2014 Total hip arthroplasty accounted for nearly 80% of overall arthroplasties, while hemiarthroplasty and revision arthroplasties accounted for approximately 10% each (Figure 15). Hip resurfacing continues to be performed but has fallen to less than 1% of arthroplasties overall. This is a dramatic change, since in recent years resurfacing represented approximately 10% of all hip arthroplasties, with European countries and Australia reporting that hip resurfacing ranged between 6% to 9% of all hip arthroplasties 7,8. Figure 17: Gender Distribution of Hip Resurfacing Procedures (N=747) Male n=614 (82.20%) Female n=133 (17.80%) Figure 15: ICD-9 Procedure Codes for All Hip Procedures (N=82,841) 81.51: Total hip replacement n=65,879 (79.5%) 81.52: Partial hip replacement/ Hemiarthroplasty n=7,958 (9.6%) 00.7: Hip revision n=8,257 (10.0%) 00.8: Hip resurfacing n=747 (0.9%) See Appendix E for a complete listing of procedure codes included in each category. Hip Resurfacing Hip resurfacing has become highly concentrated to a very small number of centers and surgeons (Figure 16). Only 63 hospitals submitted resurfacing procedures. Three of those hospitals ( A, B, and C) accounted for n=443 (42.7%) of all resurfacing procedures. There were three surgeons who performed most or all of these resurfacing procedures (data not shown). One surgeon each at s A and B performed 100% of the resurfacing procedures and another surgeon performed 90% of procedures at C. Furthermore, Figure 17 shows that the majority (82.2%) of hip resurfacing procedures were conducted on males. Hip resurfacing was defined as any ICD-9 Procedure Code of 00.85, 00.86, or 00.87. Hemiarthroplasty Arthroplasty for femoral neck fracture is an increasingly common procedure performed by both general orthopaedic surgeons and arthroplasty specialists. This is due to the shift in national demographics and the rise in the number of people over age 65. Analyses were conducted for hemiarthroplasty in 2013-2014 only, as the reported incidence of this procedure was very small in 2012. In 2013-2014, a total of 214 hospitals submitted over 7,000 hemiarthroplasty procedures performed by 1,504 surgeons. As seen in Figures 18 and 19, 94.9% (6,810/7,175) of hemiarthroplasties were conducted for the diagnosis of femoral neck fracture. The remaining 5.1% of hemiarthroplasty (n=365) were conducted for more generic codes such as 719.45 (pain in joint pelvic region and thigh) or the diagnosis was not reported. There also appears to be an increasing trend toward THA for patients with femoral neck fracture (Figure 19). The majority (69.3%) of hemiarthroplasties for femoral neck fractures were performed on females (data not shown). American Joint Replacement Registry 2014 Annual Report 13

Figure 18: Hemiarthroplasty As a Percentage of All Hip Arthroplasty Procedures in 2013-2014 (N=7,175) Percent of All Hip Arthroplasty 12% 10% 8% 6% 4% 2% 0% 9.3% n=2,287 10.4% n=4,888 2013 2014 Hemiarthroplasty was defined as any ICD-9 procedure code of 81.52. Figure 19: Hemiarthroplasty and Total Hip Arthroplasty Performed for the Diagnosis of Femoral Neck Fracture (N=6,810) Percent of All Femoral Neck Fractures 100% 80% 60% 40% 20% 0% n=548 (17.9%) n=2,463 (80.3%) 2013 2014 Hemiarthroplasty n=1,061 (19.1%) n=4,347 (78.3%) THA Diagnosis codes for femoral neck fracture included: 733.14 - Pathologic fracture, neck of femur and all codes included in 820 Fracture of neck of femur. Component Metrics: Hips Femoral head diameter choice at the time of hip arthroplasty has shown some increase for 36 mm sizes in this sample over the past three years. There is also a corresponding decrease in those less than 28 mm, with overall nearly 85% of heads measuring 32mm or larger for all three years (Table 2). Table 2: Frequency and Percentage of Femoral Head Sizes Implanted by Year (N=74,833) 2012 n(%) 2013 n(%) 2014 n(%) <28mm 537 (4.9) 704 (3.2) 1,176 (2.8) 28mm 1,049 (9.6) 2,902 (13.2) 5,752 (13.7) 32mm 3,112 (28.5) 6,025 (27.4) 10,790 (25.7) 36mm 4,890 (44.8) 9,828 (44.7) 19,607 (46.7) 40mm 808 (7.4) 1,165 (5.3) 2,225 (5.3) >40mm 515 (4.7) 1,363 (6.2) 2,435 (5.8) Total 10,911 21,987 41,985 Excludes hemiarthroplasty There has also been an increase in the use of ceramic femoral heads (versus cobalt chromium), which may be due both to the appeal of the improved wear properties of ceramic on conventional polyethylene but also very likely because of recent corrosion concerns with metal heads 16 20. Available AJRR data show that in this sample of the U.S. experience there has been a steady and relatively rapid increase in the use of ceramic heads over the past three years, with ceramic heads currently utilized for nearly half of all hip arthroplasties (Figure 20). Figure 20: Composition of Femoral Heads (N=78,065) Percent of All Hip Arthroplasty 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% n=4,013 (38.7%) n=6,350 (61.3%) 2012 2013 2014 Cobalt Chromium n=10,689 (44.0%) n=13,613 (56.0%) n=21,254 (49.0%) Ceramic n=22,146 (51.0%) Ceramic head usage has been biased toward younger patients, accounting for the majority of all arthroplasties in those under age 60 and diminishing usage with each decade of advancing patient age thereafter (Figure 21). Since 2012, there has been a noticeable increase in ceramic head use overall mainly due to a rise in usage in younger patients: nearly three out of four patients in their 50s and younger receive ceramic heads. It is also the case that some surgeons tend to use ceramic heads preferentially for larger diameter balls. Data show a modest increase in usage of ceramic 36 mm heads compared to other head sizes (Figure 22). 14 American Joint Replacement Registry 2014 Annual Report

Figure 21: Ceramic Femoral Head Usage by Patient Decade of Life (N=35,956) Figure 23: Frequency and Percentage of Dual Mobility Cups Implanted by Year (N=1,386) 100% 8% Percent of All Primary Hip Arthroplasty 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 10s 20s 30s 40s 50s 60s 70s 80s 90s Patient Age by Decade of Life 2014 2013 2012 Percent of All Hip Arthroplasty 7% 6% 5% 4% 3% 2% 1% 0% 7.0% 7.0% 6.9% n=75 n=157 n=287 1.7% 1.2% 1.1% n=164 n=251 n=452 2012 2013 2014 Primary Revision Figure 22: Composition of Femoral Heads by Size (N=74,833) Percent of Implanted Femoral Heads 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 43.7% 56.3% 45.2% 54.8% Cobalt Chromium 51.7% 48.3% 28mm 32mm 36mm 40mm Femoral Head Size Ceramic 46.2% 53.8% Dual mobility articulations were developed in Europe and have gained interest recently in the United States due to the claim of enhanced hip stability and reduced risk of dislocation they provide 9 11. Overall usage in this Registry cohort sample of the U.S. experience has been around 1.6% of all hip arthroplasties over the past three years. However, dual mobility cups were utilized in approximately 7.0% of all revision hip arthroplasties but only 1.3% of all primary THA procedures (Figure 23). As seen in Figure 24, use of enhanced polyethylene (either highly cross-linked or vitamin E impregnated) now accounts for the majority of hip arthroplasty procedures in the United States. This is certainly due, not only to earlier wear and osteolysis problems with conventional polyethylene, but also is in response to the availability of longer term data on the effectiveness of cross-linked polyethylene in reducing clinically evident wear and osteolysis 12 15. AJRR believes the data in this section underrepresent the use of cross-linked polyethylene due to reporting ambiguity. As the detailed attributes of each implant code become available over the next year, greater data completeness and precision can be expected. Figure 24: Polyethylene Usage in Acetabular Liners (N=71,925) Number of Procedures 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 n=823 (7.7%) n=7,282 (68.3%) Cross-Linked Polyethylene n=2,561 (24.0%) n=2,355 (10.1%) n=7,784 (33.3%) n=13,241 (56.6%) 2012 2013 2014 Conventional Polyethylene n=4,428 (11.7%) n=11,552 (30.5%) n=21,899 (57.8%) Antioxidant Polyethylene American Joint Replacement Registry 2014 Annual Report 15

Revision Data: Hips Between 2012 and 2014, data were collected on 8,257 revision hip arthroplasties. Of these, 920 (11%) were linked revision arthroplasties where data on the earlier primary THA were also available in the Registry for analysis. Overall, in the larger cohort of 8,257 revision procedures, the predominant cause for revision by diagnosis code was aseptic mechanical, with the four codes for mechanical loosening, other mechanical, wear, and osteolysis (the last two which often co-exist and are interrelated) accounting together for 41.3% of revisions recorded (Figure 25). Dislocation was the next most common diagnosis, accounting for 13.9%, with infection (7.7%) and periprosthetic fracture (4.0%) less common. In the 920 linked hip arthroplasty revisions where data were also available on the original primary THA, over 70% occurred within the first three months post surgery (Table 3). This may be due to the relatively short period of data collection for this Registry from many of the AJRR participating hospitals. It may also be because of the likely bias toward early revision procedures, which is due to the likelihood of early failures returning to the original (AJRR participating) facility. This is compared to late revision cases that may be more often cared for at a different hospital, which may or may not be reporting to AJRR. Fewer than 7% of these linked procedures were revisions performed over one year post primary arthroplasty. Table 3: Time Interval between Primary Hip and Revision for Linked Patients (N=920) < 3 Months 3-6 Months 6-12 Months > 1 Year 672 108 77 63 Therefore, the diagnoses that account for revision in this subset are clearly biased toward early cause of revision arthroplasty, which may be less often affected directly by the implant s performance and more related to surgical technique and patient comorbidities. Indeed, dislocation is the leading cause of failure in these largely early revisions, accounting for 20%, and it is closely followed by infection in 16%, and fracture in 13.2% (Figure 26). Dislocation and infection were the leading causes of early revision procedures following total hip arthroplasty (Figure 27). Figure 25: ICD-9 Diagnosis Codes for All Hip Revisions (N=8,257) 996.41: Mechanical loosening of prosthetic joint n=1,299 (15.7%) 996.47: Other mechanical complications n=1,323 (16.0%) 996.42: Dislocation of prosthetic joint n=1,149 (13.9%) 996.66: Infection and inflammatory reaction n=639 (7.7%) 996.46: Articular bearing surface wear n=521 (6.3%) 996.44: Peri-prosthetic fracture n=331 (4.0%) 996.45: Peri-prosthetic osteolysis n=269 (3.3%) All other codes n=2,726 (33.0%) Figure 26: ICD-9 Diagnosis Codes for Linked Hip Revisions (N=920) 996.42: Dislocation of prosthetic joint n=184 (20.0%) 996.66: Infection and inflammatory reaction n=147 (16.0%) 996.44: Peri-prosthetic fracture n=121 (13.2%) 996.47: Other mechanical complication n=55 (5.9%) 996.41: Mechanical loosening of prosthetic joint n=54 (5.9%) All other codes n=359 (39.0%) Figure 27: Most Frequently Reported ICD-9 Diagnosis Codes for Hip Revisions (<3 Months to Revision) Number of Early Hip Revision Procedures 140 120 100 80 60 40 20 0 n=117 (17.4%) 996.42 Dislocation of prosthetic joint n=114 (17.0%) 996.66 Infection and inflammatory reaction due to internal joint prosthesis n=107 (15.9%) 996.44 Peri-prosthetic fracture around prosthetic joint n=31 (4.6%) 996.47 Other mechanical complication of prosthetic joint implant n=20 (3.0%) 996.41 Mechanical loosening of prosthetic joint 16 American Joint Replacement Registry 2014 Annual Report

Knee Arthroplasty Procedural Data: Knees The mean age of patients having knee arthroplasty was 66.1 years (SD 10.4), which is similar to the mean age for hip arthroplasty (Figures 13 and 28). Findings demonstrate a slight decrease compared to last year when the mean age for knee arthroplasty was 66.7 years. It will be interesting in the years ahead to see if this small change continues to be consistent with the gradual decrease in mean age for hip arthroplasty reported by others over the past several decades 21. _ x = 67.6, SD = 12.8 Figure 28: Age Distribution of All Knee Procedures (N=128,880) 6,000 Number of Knee Arthroplasty Procedures 5,000 4,000 3,000 2,000 1,000 0 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 54 56 58 60 62 64 66 68 70 72 74 76 78 80 82 84 86 88 90 92 94 96 98 100 Age of Patient American Joint Replacement Registry 2014 Annual Report 17

Osteoarthritis was the underlying or original diagnosis for nearly 95% of knee arthroplasties, with rheumatoid arthritis accounting for a fraction of one percent of all arthroplasties performed (similar to the pattern in hip arthroplasty) (Figures 14 and 29). This is likely attributable to the impact disease-modifying drugs and other enhanced medical management strategies have on the preservation of major joint function in patients with inflammatory arthropathies 22. Revision procedures accounted for 8.1% of knee arthroplasties performed overall, with the rest primary arthroplasties of some type. Figure 29: ICD-9 Diagnosis Codes for All Primary and Revision Knee Arthroplasty (N=118,460) 715: Osteoarthritis n=112,187 (94.7%) 996: Complications n=1,690 (1.4%) Other n=4,251 (3.6%) 714: Rheumatoid arthritis n=332 (0.3%) Figure 30: ICD-9 Procedure Codes for All Knee Arthroplasty (N=128,880) 81.54: Total knee replacement n=118,345 (91.8%) 00.8: Revision knee replacement n=10,420 (8.1%) Other knee procedures n=115 (0.1%) Other codes include those in categories 716, 719, 733, 736, and 755. See Appendix F for complete listing of diagnosis codes included in each category. See Appendix G for complete listing of procedure codes included in each category. Please note that the number of diagnosis codes does not equal the number of procedure codes as a diagnosis code may be found that does not match the procedure code. If that occurs, and the components match the procedure code, the diagnosis code is not counted. Component Metrics: Knees Posterior stabilized type implants were the most frequent category used in primary knee arthroplasty procedures in this sample (Figures 31 and 32), accounting for approximately 58% over the three-year span. Cruciate retaining type implants were next most common and made up 30% of the total over the same time frame. Complex procedures requiring increased constraint or hinged devices made up only 2% of the total. Figure 31: Knee Implant Design by Year (N=125,554) 70% Percent of All Primary Knee Arthroplasty 60% 50% 40% 30% 20% 10% 0% 56.9% 29.9% 4.9% 2012 1.8% 0.1% 6.3% 61% 27.3% 55.6% 31.7% 4.3% 5.7% 6.8% 4.2% 1.6% 0.1% 1.6% 0.1% 2013 2014 Posterior Stabilized Cruciate Retaining Congruent Type Constrained Type Hinge Type Other/Unknown 18 American Joint Replacement Registry 2014 Annual Report

Figure 32: Tricompartmental Knee Implant Design, Cumulative (N=125,554) 70% Percent of All Primary Knee Arthroplasty 60% 50% 40% 30% 20% 10% 0% 57.8% Posterior Stabilized 29.6% Cruciate Retaining 4.5% Congruent Type 1.7% Constrained Type 0.1% Hinge Type 5.4% Other/Unknown Unicompartmental knee arthroplasties accounted for approximately one in 20 knee arthroplasty procedures overall, with a slight downward trend from 6% to 4% over the three years reported (Figure 33). While unicompartmental procedures were performed at a majority of hospitals participating in AJRR during the three years under review, only one in four surgeons with arthroplasty procedures reported to AJRR that they performed unicompartmental procedures during the same year (Table 4). Figure 33: Unicompartmental Knee Arthroplasty As a Percentage of All Knee Arthroplasty (Based on Femoral Components Implanted) (N=6,858) Percent of All Knee Arthroplasty 7% 6% 5% 4% 3% 2% 1% 6.0% 5.0% 4.2% n=1,274 n=2,383 n=3,201 Table 4: Unicompartmental Knee Arthroplasty Utilization Surgeons performing unicompartmental knee arthroplasty s performing unicompartmental knee arthroplasty 2012 n (%) 158 (22.6%) 46 (56.1%) 2013 n (%) 362 (24.5%) 115 (72.3%) 2014 n (%) 560 (24.9%) 186 (78.8%) 0% 2012 2013 2014 American Joint Replacement Registry 2014 Annual Report 19

Polyethylene inserts were categorized as Conventional Polyethylene, Cross-Linked Polyethylene, or vitamin E impregnated/antioxidant Polyethylene. For primary knee arthroplasty procedures performed from 2012 to 2014, usage rates of conventional polyethylene and cross-linked polyethylene were nearly identical but declined slightly from 48% to 50% for each in 2012 to around 43% for both types by 2014 (Figure 34). This decline was balanced by a steady increase in the use of antioxidant polyethylene over the same time frame from 2% in 2012 to nearly 15% by 2014. In contrast, polyethylene usage in revision knee arthroplasty involved conventional polyethylene in two out of three revision procedures overall. Around one third of revision TKA patients received cross-linked polyethylene; this figure declined slightly over the three year period and was balanced by a rise in antioxidant polyethylene from near nil in 2012 to around 5% in 2014 (Figure 35). Figure 34: Percentage of Polyethylene Usage by Year in Primary Total Knee Arthroplasty (N=116,288) Figure 35: Percentage of Polyethylene Usage by Year in Revision Total Knee Arthroplasty (N=9,696) 60% 70% Percent of All Primary Knee Arthroplasty 50% 40% 30% 20% 10% Percent of All Primary Knee Arthroplasty 60% 50% 40% 30% 20% 10% 0% 2012 2013 2014 0% 2012 2013 2014 Polyethylene Cross-Linked Polyethylene Antioxidant Polyethylene Polyethylene Cross-Linked Polyethylene Antioxidant Polyethylene Patellar resurfacing is the predominant practice in North America in contrast to Scandinavia and other parts of Europe 23. This is evident in the data, with over 80% of patients receiving a patellar component (Figure 36). Figure 36: Percentage of Knee Arthroplasty with and without Patellar Resurfacing (N=109,829) 100% Percent of All Knee Arthroplasty 80% 60% 40% 20% 17.8% 82.2% 18.5% 81.5% 18.2% 81.8% 0% 2012 2013 2014 Without Patella With Patella 20 American Joint Replacement Registry 2014 Annual Report

Revision Data: Knees The main cause of revision as indicated by diagnosis codes were aseptic loosening, wear, or mechanical causes of failure in the majority of over 10,000 procedures collected, with infection accounting for 9.1% overall (Figure 37). A total of 639 of these revisions were linked procedures, which had data in the Registry relating to the original primary procedure as well. Figure 37: ICD-9 Diagnosis Codes for Knee Revisions (N=10,420) 996.41: Mechanical loosening of prosthetic joint n=1,938 (18.6%) 996.47: Other mechanical complication n=1,565 (15.0%) 996.66: Infection and inflammatory reaction n=948 (9.1%) 996.7: Other complications due to unspecified device implant n=766 (7.4%) 996.42: Dislocation of prosthetic joint (incl. instability) n=613 (5.9%) 996.46: Articular bearing surface wear n=521 (5.0%) All other codes n=4,069 (39.0%) Of the linked revision procedures with data on both primary and revision surgeries in the Registry, 41.9% were performed in the first three months post surgery and only 22.1% were performed more than a year after the primary procedure (Table 5). In keeping with this bias toward early revision procedures, aseptic problems of wear, or mechanical failure were less frequent than infection, which accounted for more than one in four of these relatively early revision procedures (Figure 38). Table 5: Time Interval between Primary Knee and Revision for Linked Patients (N=639) < 3 Months 3-6 Months 6-12 Months > 1 Year 268 96 134 141 Figure 38: ICD-9 Diagnosis Codes for All Linked Knee Revisions (N=639) 996.66: Infection and inflammatory reaction n=174 (27.2%) 996.47: Other mechanical complication n=68 (10.7%) 996.7: Other complications due to unspecified device implant n=57 (8.9%) 996.42: Dislocation of prosthetic joint (incl. instability) n=53 (8.3%) 996.41: Mechanical loosening of prosthetic joint n=51 (8.0%) All other codes n=236 (36.9%) Infection was the leading cause of early revision procedures following a primary knee arthroplasty, accounting for 43% of all of these early procedures (Figure 39). Figure 39: Most Frequently Reported ICD-9 Diagnosis Codes for Early Knee Revisions (<3 Months to Revision) (N=268) 120 Number of Early Knee Revision Procedures 80 40 0 n=114 (42.5%) 996.66 Infection and inflammatory reaction due to internal joint prosthesis n=14 (5.2%) 996.7 Other complications due to internal prosthetic device, implant, and graft n=13 (4.9%) 996.42 Dislocation of prosthetic joint n=10 (3.7%) 996.47 Other mechanical complication of prosthetic joint implant n=6 (2.2%) 996.44 Peri-prosthetic fracture around prosthetic joint American Joint Replacement Registry 2014 Annual Report 21

Level II and III Update and Data Reporting In 2014, AJRR conducted a pilot program identifying automated methods to acquire Level II data and to test the features implemented to manage the Level III/ PROMs process. The pilot was not intended to address a particular hypothesis or to enable conducting complex analyses. AJRR solicited volunteers from its pool of participating hospitals, which at the time was approximately N=220. s were asked to submit Level II elements where possible. A total of N=23 hospitals expressed interest in participating, including multi-hospital systems. s were asked to submit data on the following elements, if possible. American Society of Anesthesiologists (ASA) Classification Antibiotic Prophylaxis and Type Antithrombolytics and Type Beta Blocker Administered HgA1c Value and Date Patient Height and Weight/Body Mass Index (BMI) Pre- and Post-Op Visit Date Procedure Start and End Time (or Procedure Duration) Serum Albumin Value and Date Total Lymphocyte Value and Date Comorbidities Chronic Lung Disease Congestive Heart Failure (CHF) Coronary Artery Disease Dialysis Diabetes Mellitus Hypertension Immunocompromised Obesity Peripheral Artery Disease Previous Cardiac Condition Venous Thromboembolism (VTE) History Complications Arrhythmia CHF Deep Vein Thrombosis (DVT) Any and Proximal Dislocation Excessive Bleeding Fracture Myocardial Infarction Nerve Injury Pulmonary Embolism Renal Failure Wound Complication Wound Infection In the end, 20 hospitals participated in the pilot program, and submitted data on N=8,126 procedures. s were located in 11 states representing Eastern, Central, and Pacific Northwest regions of the United States. No pilot hospitals were in the Mountain or South Pacific regions. As seen in Figures 40 and 41, pilot hospitals were disproportionately large or small sized hospitals and non-teaching facilities when compared to medium-sized teaching facilities. Figure 40: Teaching Affiliation of Submitting s (N=19)* Major Teaching n=2 (10.5%) Minor Teaching n=4 (21.1%) Non-Teaching n=13 (68.4%) Source: FY2013 AHA Annual Survey Database * Please note data were not available for one of the pilot hospitals. 22 American Joint Replacement Registry 2014 Annual Report

Figure 41: Size (Bed Count) of Level II Pilot s (n=19)* Table 7: Demographic Distribution of Level II Pilot Patients (N=8,126) Small n=6 (31.6%) Hips (n=3,455) Knees (n=4,671) Medium n=8 (42.1%) Large n=5 (26.3%) Age (SD) 65.7 (SD 12.0) 67.0 (SD 9.8) Gender n=3,438 n=4,649 Female 1,846 (53.7%) 2,711 (58.3%) Male 1,592 (46.3%) 1,938 (41.7%) Source: FY2013 AHA Annual Survey Database * Please note data were not available for one of the pilot hospitals. All hospitals were able to extract and report data on patient comorbidities (ICD-9) and ASA class. Unfortunately, the submission of lab values proved challenging, as seen by the frequencies in Table 6 below. Table 6: Lab Value Results for Level II Pilot s Lab Test n Mean Value (SD) Serum albumin 1,171 4.1 g/dl (SD = 0.6) Total lymphocyte 1,791 144.6 cells/µµl (SD = 529.2) HgA1c 791 7.23% (SD = 22.7) Surgical approach was an optional variable, submitted by four hospitals (data not shown). Table 7 shows the demographic composition of the participants in the pilot study. While most hospitals were able to submit data for age, gender, BMI, and ASA class, race and ethnicity data were challenging for some sites. This is consistent with findings for Level I data submission. Some sites do not wish to submit such data, or others have a different format for race and ethnicity not consistent with AJRR s format (i.e., race and ethnicity combined into one category). Variable Procedure Duration was not consistently reported. However, those that did report demonstrated a mean time for hip arthroplasty (n=2,200) of 1 hour, 27 minutes (SD 35 minutes) and a mean time for knee arthroplasty (n=3,183) of 1 hour 33 minutes (SD 34 minutes). There was a paucity of data on computer assisted procedures and length of stay (data not shown). BMI (kg/m2) 29.02 (SD 6.1) 32.4 (SD 6.8) Race n=3,117 n=4,147 White 2,887 (92.6%) 3,792 (91.4%) Black/African American 140 (4.5%) 228 (5.5%) Asian 70 (2.3%) 99 (2.4%) American Indian 14 (0.5%) 18 (0.4%) Native Hawaiian 6 (0.2%) 10 (0.2%) Ethnicity n=2,961 n=3,801 Non-Hispanic 2,935 (99.1%) 3,758 (98.9%) Hispanic 26 (0.9%) 43 (1.1%) ASA Classification n=3,394 n=4,575 I 302 (8.9%) 203 (4.4%) II 2,075 (61.1%) 2,732 (59.7%) III 984 (29.0%) 1,584 (34.6%) IV 33 (1.0%) 56 (1.2%) American Joint Replacement Registry 2014 Annual Report 23

All 20 participating hospitals were able to submit at least some comorbidity data (Table 8). Unfortunately, obesity, coronary artery disease, and peripheral artery disease were not consistently submitted. Table 8: Comorbidities of Level II Pilot Patients ICD-9 Comorbidity Code Hips n=3,455 Knees n=4,671 Chronic Lung Disease 134 215 Coronary Artery Disease 93 210 Congestive Heart Failure 94 99 Diabetes 350 807 Dialysis 1 0 Hypertension 1,565 2,534 Immunocompromised 22 8 Obesity 159 276 Peripheral Artery Disease 27 81 Previous Cardiac 52 66 VTE 9 27 For post-operative complications data capture was inconsistent mainly due to the timing of pilot data submission (i.e., if the hospital provided retrospective data they could report complications more easily than if they submitted real time data) (data not shown). As such, only 14 hospitals submitted ICD-9 codes for complications. In summary, we determined that lab values, prophylaxis, and beta blockers were not submitted if the element was not a discrete field in the hospital EMR or if the data were not captured in hospital (i.e., the lab tests were conducted at an outside location not electronically linked with the hospital). For comorbidities and complications, AJRR will need to include more diagnosis codes to ensure adequate capture. However, ICD-10 will address this by including more granularity with coding. Finally, timing for capture of post-operative complications was a challenge. It seems that consistent reporting and clearly defined data element definitions will aid data capture in the future. AJRR thanks the following institutions for their participation in the pilot program: Bronson Methodist Doylestown Indiana Orthopaedic Kenmore Mercy Memorial (IL) Ochsner Roper St. Francis Bon Secours St. Francis Roper Roper St. Francis Mount Pleasant Southeast Georgia Health System Swedish Health Services Ballard Campus First Hill Campus Edmonds Campus Issaquah Campus ThedaCare Appleton Community Health Network/Berlin Memorial ThedaCare - New London ThedaCare - Shawano Theda Clark Western Maryland Health System 24 American Joint Replacement Registry 2014 Annual Report

Programming, Funding, and Alliances Programming and Funding At the March 2014 Board of Directors meeting, principals from Avalere Health, LLC presented the AJRR leadership and staff a report that highlighted the growing importance of U.S.-based clinical registries and the impact AJRR can make on behalf of the orthopaedic community. The detailed report identified AJRR s strengths and weaknesses in the coming years and examined relevant competition in the marketplace. While operating business efficiencies that are selfsustaining it was agreed that expanding AJRR capabilities could be rewarding for the organization. The Board gave consideration to expand the AJRR mission to collect data on a full range of orthopaedic implantable devices. The Board also directed the staff to examine ways to expand AJRR s reach into a more encompassing role that might position AJRR as the Quality Initiative for Orthopaedic Registries. Critical to AJRR s financial success is the ability to become self-sustaining, decreasing its original partners financial obligations. In 2014, AJRR implemented a fee schedule for participating hospitals. Fee payment covers the AJRR Demand Reporting & Electronic Dashboard Service, or the online quality reports, which show individual hospital data and national benchmarks. By the end of the year, licenses had been distributed to 45 institutions. Collaboration with Medical Device Manufacturers On December 18, 2014, AJRR staff met with representatives from medical device partner organizations to discuss guidelines for how these organizations will gain access and request reports on procedures where their components were implanted. During the session, it was identified that formal policies and procedures should be developed to govern the release of de-identified information pertaining to a particular manufacturer s components, as well as to document the constraints on manufacturers use and disclosure of Registry data. The team also identified the preferred method for gaining access to the information, which parallels the way manufacturers interface with other international registries. Each company attending the meeting agreed to assist AJRR in the expansion of the AJRR component reference database by providing additional component characteristics. Strategic Alliances and Affiliations American Medical Association (AMA) The National Quality Registry Network (NQRN) is an anchor program of AMA s Physician Consortium for Performance Improvement (PCPI), consisting of approximately 50 organizations that support clinical registries. The NQRN is a voluntary network of organizations that operate registries and others interested in increasing the usefulness of clinical registries to measure and improve patient health outcomes. AJRR continued in 2014 to participate on the NQRN Council and Leading Practices Committee. In 2014, NQRN became a national force for moving the clinical registry enterprise forward. It provided education and tools for registry organizations, including a guide to using registries for CMS quality measures submission under PQRS and a public preview version of its clinical registry maturational framework. Commercial Health Plans The 2014 AJRR Board of Directors included two members who represent the commercial payer community. Robert L. Krebbs is Director of Payment Innovation, Anthem, Inc. Steven H. Stern, MD, MBA, is with UnitedHealthcare as Vice President, Cardiac and Orthopaedics/Neuroscience. Dr. Stern also served on the AJRR Board of Directors and Executive Committee as Secretary/Treasurer. The Joint Commission AJRR continued efforts that began in 2012, by establishing productive discussions with The Joint Commission that were focused on recognizing hospitals that submitted data to AJRR. The AJRR Public Advisory Board membership includes a representative from The Joint Commission (Ms. Margaret VanAmringe), and continues to have an active collaborative relationship with The Joint Commission on a variety of topics. The Pew Charitable Trusts AJRR continues to dialogue with the Pew Charitable Trusts about the Food and Drug Administration s (FDA) UDI system requirements and the FDA s regulation regarding UDI. AJRR s Medical Director Dr. David Lewallen has represented AJRR at numerous sessions to discuss the roll out and how it affects AJRR s ability to capture UDI as a data element. American Joint Replacement Registry 2014 Annual Report 25

Physician Clinical Registry Coalition This coalition is a group of 23 medical societysponsored or physician-led clinical data registries working together to advocate for public policy changes that will promote the development of registries and strive to remove barriers to the registries. AJRR Executive Director Jeffrey Knezovich and AJRR Government Relations Specialist Judi Buckalew are active members of the coalition. Government, Advocacy, and Public Affairs On January 1, 2014, AJRR opened a government advocacy office in Washington, D.C. in cooperation with shared resources from AAOS. The early activities focused on AJRR advocacy objectives, training on regulatory advocacy, along with arranging, staffing, and providing follow-up to CMS meetings to discuss implementation of the QCDR program and barriers to hospital participation in registries. The last quarter of 2014 produced several successes for AJRR. These included the addition of the Common Rule exception language in the House Ways and Means Medicare legislative package coupled with House Energy and Commerce Committee adoption of H.R. 5214, a clinical data registry bill. AJRR led the medical community through the Physician Clinical Registry Coalition in securing these achievements. Additional government-related activities and initiatives are described below. Agency for Healthcare Research and Quality (AHRQ) Launched on December 1, 2012, the Registry of Patient Registries (RoPR), an AHRQ initiative, provides a searchable database of existing patient registries in the United States. AJRR is an official enrollee in RoPR and the information can also be found at www.clinicaltrials.gov, a repository and results database of publicly and privately supported clinical studies of human participants conducted around the world. Centers for Medicare & Medicaid Services (CMS) The Board of Directors and senior staff continue to meet with CMS staff to provide education in Washington, D.C. about AJRR s activities and role in the orthopaedic community. AJRR has encouraged CMS to develop incentives for hospitals to participate in Registry efforts. Such discussions are ongoing. The QCDR initiative was designed to be an additional pathway for eligible professionals to participate in PQRS. In May 2014, AJRR was selected as one of 39 entities across medicine to be a QCDR, and the only entity in orthopaedics selected for this distinction. To fully implement the QCDR program requirements, AJRR partnered with CECity, a leading provider of cloud-based registry platforms for performance improvement and value-based payment, to create the custom platform for data submission to CMS. The CECity platform ensures that eligible professionals meet all of the data, scoring, and attestation requirements before they submit their PQRS reports to CMS for payment. The CECity system (AJRR Orthopaedic Resource Center) was launched in October 2014. AJRR Board Vice Chair Dr. Daniel Berry also served on a Technical Expert Panel convened by CMS and the Office of the National Coordinator for Health Information Technology (ONC), which provided input on key measure decisions for hospital- and physician-level patient-reported outcome measures. Dr. Kevin Bozic, Co-Chair of the AJRR Regulatory Committee, served as the technical expert for the Yale New Haven Health Services Corporation Center for Outcomes Research and Evaluation (CORE) Project Team, which directed the initiative. Food and Drug Administration (FDA): Center for Devices and Radiological Health (CDRH) In 2007, a law was signed to establish a UDI System that required (a) the label of a device to bear a unique identifier; (b) the unique identifier to identify the device through distribution and use; and (c) the unique identifier to include the lot or serial number if specified by the FDA. On September 20, 2014 the FDA announced a final rule for the UDI system. AJRR prepared comments regarding the appropriateness of UDI collection for a registry. AJRR s comments were well received and played a role in the final ruling about when the first package will be identified with UDI. Additionally, AJRR Board Chair Dr. William Maloney was selected to be a member of the National Medical Device Registries Task Force. The group was asked to address the implementation of registries in postmarket surveillance and throughout the total product life cycle. The task force is coordinated through the Medical Device Epidemiology Network (MDEpiNET) Public-Private Partnership (PPP) initiative (www.mdepinet.org), which is part of the CDRH. MDEpiNET is a collaborative program through 26 American Joint Replacement Registry 2014 Annual Report

which CDRH and external partners share information and resources to advance a national and international infrastructure for patient-centered regulatory science, surveillance, and quantitative methods. The initiative outputs will result in optimized evidence generation, appraisal, and synthesis for medical device Total Product Life Cycle evaluation. AJRR also continues to work with The Knee Society, The Hip Society, and AAHKS to include performance measures being developed and approved for CMS s PQRS initiative. These measures, as they become approved and available, will be part of AJRR s QCDR quality data set that surgeons will use to qualify for additional payment and/or avoid penalties under PQRS. Other Arthroplasty Registries While AJRR is the first National Arthroplasty Registry in the United States, there are several other statebased U.S. arthroplasty registries, including the California Joint Replacement Registry (CJRR) and the Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI). Collaboration with both CJRR and MARCQI enables rapid recruitment and resultant data acquisition. AJRR continues to dialogue with these organizations to minimize the burden of data submission and maximize the value of the information collected. See Preliminary 2015 Accomplishments for more information regarding CJRR. International Society of Arthroplasty Registers (ISAR) ISAR is a global consortium of joint replacement registries (www.isarhome.org) established by several of the mature national registries. The society facilitates the development of registry science and observational studies, encourages the development of new national registries around the world, and provides a forum for information sharing to enhance participating countries ability to meet their own objectives. ISAR also assists in the development of collaborative activities and provides support to both established and developing registries, such as AJRR. AJRR is an active participant and member of ISAR and served as co-host for the Third International Congress of Arthroplasty Registers, held May 31-June 2, 2014 in Cambridge, Massachusetts. International Consortium of Orthopaedic Registers (ICOR) ICOR was established by the FDA and rolled out during a workshop in May 2011 (www.icor-initiative.org). The intent of the workshop was to facilitate discussion among FDA and worldwide orthopaedic registries that have orthopaedic implant information, in order to further collaborate through a research network that pools the collective experience and available data. Dr. David Lewallen serves as a member of the ICOR steering committee. Ongoing ICOR projects include (a) development of a worldwide implant database; (b) comparison of various bearings used in hip arthroplasty; and (c) comparison of fixed and mobile bearings used in knee arthroplasty. ArthroplastyWatch ArthroplastyWatch is a Swedish-based information project developed in 2011 2012 (www. arthroplastywatch.com) supported by the Swedish government but freely available to the public. The project is intended to collect data on implant recalls or alerts, and arthroplasty safety issues from around the world and from a variety of sources. This information is then disseminated online via a publicly available website. Data are continually collected, updated, and monitored by a team of experts, such as Dr. David Lewallen, who is a member of the ArthroplastyWatch Advisory Board. Operation Walk USA Last year marked the fifth annual Operation Walk USA event. In early December 2014, 55 surgeons performed total joint replacements on 82 under- or uninsured individuals. Prior to Operation Walk USA, these individuals were unable to receive the care they desperately needed, and many experienced substantial pain and disability. AJRR is proud to be a partner with this organization. AJRR s data collection software houses the basic demographic and procedural data collected on these patients so that the staff and surgeons of Operation Walk USA can track outcomes of these procedures over the coming years. DePaul University Master of Public Health Program During the 2013 2014 academic year, AJRR was a practicum site for a student at the DePaul University Master of Public Health program. Ms. Allison Stunard assisted AJRR with the launch and implementation of the Level II and Level III pilot program and developed a comprehensive orientation and training manual that has been used by new employees and new Board members. American Joint Replacement Registry 2014 Annual Report 27

Preliminary 2015 Accomplishments As of January 1, 2015, AJRR became a selfsustaining, independent organization. AJRR is grateful to the AAOS for their many years of support. As of October 1, AJRR increased hospital enrollment to N=577. New enrollees included large health systems such as Advocate Health Care, Allina Health, Intermountain Healthcare, and all Providence Health & Services locations across five states. 428 hospitals are submitting data, up from 285 submitting as of January. 336,574 total procedures received since inception. Increase in Enrollment 2010-2015 2010 2011 2012 2013 2014 2015 6 15 122 242 417 577 On April 1, the California Joint Replacement Registry (CJRR) and AJRR completed the transfer of CJRR to AJRR. This relationship between the two organizations will help advance the mission to provide better outcomes for patients having total hip and knee arthroplasties in California and throughout the United States. Over several years, the two registries have aligned data elements, shared resources, and supported shared policy objectives. AJRR was again selected by CMS to be a QCDR, one of only 49 throughout the United States. A QCDR is a reporting mechanism available for PQRS. For program year 2015, AJRR added data elements that allow coverage of other orthopaedic procedures beyond total knee replacement and launched the new reporting site in August. Partnering with various orthopaedic specialty societies, AJRR is preparing the Registry for collection of Level II and III data based on their current guidance. AJRR staff completed the requirements to implement ICD-10 on the AJRR data system prior to the October 1, 2015 launch. A key part of this effort has been to develop an appropriate crosswalk for triggering procedure codes and relevant diagnosis codes. Many thanks to the hospitals and colleagues who have worked with AJRR staff on this important effort. AJRR staff hosted many webinars and information sessions to assist hospital IT and administrative staff in this transition as it pertained to data submission. In addition to accepting ICD-9 and ICD-10 codes, AJRR has added the capability to collect Current Procedural Terminology (CPT) codes. With CPT codes, AJRR will be able to accept Registry data directly from individual surgeons or private practice groups. During the AAOS Annual Meeting, AJRR hosted the first User Group meeting. Current Registry users comprised an expert panel facilitating a question and answer session for interested parties. The AJRR User Group is a forum for those who participate in the Registry to share ideas and best practices, network, and learn in the field of orthopaedics. Any participant can become a member. AJRR 2015 Milestones >250K c AJRR CJRR x500 Over 250,000 Procedures in Registry, Achieving End-of-Year Goal in April Formation of AJRR User Group Network Merger of California Joint Replacement Registry (CJRR) into AJRR 500 th Enrolled 28 American Joint Replacement Registry 2014 Annual Report

The AJRR Total Joint Replacement Risk Calculator became available on the AJRR website. Ortho Apps, a collaborative of Massachusetts General, Mayo Clinic, and the University of California, San Francisco, developed the calculator. Surgeons can use it to assess the risk of prosthetic joint infection and mortality for patients undergoing a joint replacement procedure based on their comorbidities and demographics. The AJRR Total Joint Replacement Risk Calculator is free to access. Surgeons can input patient risk factors to receive the calculated risk for the patient receiving the procedure. To maintain and enhance the component reference database, AJRR continues to collaborate with ICOR, ISAR, other international registries, and industry experts to expand the individual component information attribute characteristics and to add newly launched components to the AJRR reference database. AJRR, with the assistance of the AOANJRR, conducted a matching analysis to identify common and unique components of the AJRR and the ICOR database. In 2015, AJRR also entered into a relationship with Mendenhall Associates, Inc. to obtain additional data services related to device characteristics augmenting the AJRR reference data. In July 2015, AJRR launched a completely new website www.ajrr.net. This new site allows current users and interested individuals to easily access information about AJRR and connect with staff and other Registry participants. Users can access the Registry via a secure log-in. A secure log-in area is also available for AJRR Board members to retrieve important materials and User Group members to facilitate discussion, retrieve materials, and register for events. Additionally, those who are interested in our participating sites can search through a list organized by state or utilize an interactive map that shows where each hospital is located, along with some information about that institution. AJRR s new website www.ajrr.net. American Joint Replacement Registry 2014 Annual Report 29

Appendix A 2014 AJRR Committee Members Data Management Committee Daniel J. Berry, MD Chair Mayo Clinic David C. Ayers, MD University of Massachusetts Michael P. Dohm, MD University of Arizona Patricia D. Franklin, MD, MBA, MPH University of Massachusetts Blair Fraser Smith & Nephew Stephen E. Graves, MD Australian Orthopaedic Association National Joint Replacement Registry Brian R. Hallstrom, MD University of Michigan Richard E. Hughes, PhD University of Michigan David G. Lewallen, MD Mayo Clinic Hilal Maradit-Kremers, MD Mayo Clinic David G. Mekemson Public Advisory Board Representative David E. Mino, MD, MBA Cigna Healthcare Colin Nelson, BA Informed Medical Decisions Foundation Pamela L. Plouhar, PhD DePuy Synthes Sarah Shi Stryker Scott M. Sporer, MD Midwest Orthopaedics at Rush and Central DuPage Bryan D. Springer, MD OrthoCarolina Jing Xie, PhD Zimmer Finance and Compensation Committee Steven H. Stern, MD, MBA Chair United Healthcare John A. Canning, Jr. Madison Dearborn Partners, LLC Terence J. Gioe, MD University of Minnesota Minneapolis Veterans Affairs Kristen Murtos, MBA Skokie Regulatory Committee E. Anthony Rankin, MD Co-Chair Providence Kevin J. Bozic, MD, MBA Co-Chair University of California, San Francisco David A. Halsey, MD University of Vermont Medical Center David R. Mauerhan, MD Carolinas Eric Rugo, MBA Stryker Margaret Van Amringe, MHS The Joint Commission Appendix B Core Data Elements LEVEL I LEVEL ll LEVEL III LEVEL IV Patient Name (Last, First) Date of birth Social Security Number Diagnosis (ICD-9) Gender Ethnicity Name National Provider Identifier (NPI) Address Surgeon Name National Provider Identifier (NPI) Procedure Type (ICD-9) Date of surgery Laterality Patient Risk Factors/ co-morbidities (ICD-9) Chronic lung disease Congestive heart failure Coronary artery disease Diabetes mellitus Dialysis History of venous thrombosis and embolism Hypertension Obesity Peripheral artery disease Previous cardiac condition (past myocardial infarction) Post-Operative Complications Surgical approaches Prophylaxis American Society of Anesthesiologists (ASA) classification Medical Outcomes Study 36- Item Short Form Health Survey (SF-36) Hip Disability and Osteoarthritis Outcome Score (HOOS) Knee Injury and Osteoarthritis Outcome Score (KOOS) Western Ontario and McMaster Universities Arthritis Index (WOMAC) Oxford Hip Score and Knee Score Knee Society Knee Scoring System Harris Hip Score Radiographic Images Implants 30 American Joint Replacement Registry 2014 Annual Report

Appendix C 2012-2014 Participating s and Health Systems *Institutions that Submitted Data for this Annual Report Adventist - Hanford Adventist - Portland Advocate Christ Medical Center Advocate Condell Medical Center Advocate Good Samaritan Advocate Good Shepherd Advocate Illinois Masonic Advocate Lutheran General Advocate Sherman Advocate South Suburban Advocate Trinity Allegheny General Amherst Appleton Medical Ashtabula County Medical Center Aspirus Wausau Aurora BayCare Medical Aurora - Grafton* Aurora - Washington County* Aurora Sinai Medical Aurora St. Luke s Medical Ball Memorial Ballard Campus* Banner - University South Campus Baptist Easley Bayhealth Kent General* Bayhealth Milford Memorial* Baylor All Saints Medical Baylor at Carrollton* Baylor at Garland* Baylor at Irving* Baylor at McKinney* Baylor at Waxahachie* Baylor Regional Medical Center at Grapevine* Baylor Regional Medical Center at Plano* Baylor University Medical Beaumont - Royal Oak campus* Benefis Berkshire Medical Berlin Memorial Beth Israel Deaconess - Plymouth* Beth Israel Deaconess Medical Bethesda North Blessing Health System* Bluffton Regional Medical Center Bon Secours St. Francis Borgess Medical Boston Medical Bronson Methodist Buena Vista Regional Cabell Huntington Carolinas - Charlotte Carolinas - Lincoln Carondelet St. Joseph s Castle Centegra - McHenry* Centegra - Woodstock* Central Peninsula General Cheyenne Regional Medical CHI Health St. Elizabeth* Chippenham CHI St. Vincent* Cleveland Clinic Children s for Rehabilitation Cleveland Clinic Florida Clinic Weston Cleveland Clinic Foundation Community General Community Memorial of Menomonee Falls* Concord Conway Cuyuna Regional Medical Dartmouth-Hitchcock Medical Denver Health and Authority* Doctors at Deer Creek Doctors at Renaissance* Douglas County Doylestown Dukes Memorial Dupont Edmonds Campus* Eisenhower Medical Center Essentia Health - St. Mary s Euclid Evanston EvergreenHealth Medical Fairview Feather River First Hill Campus* FirstHealth Moore Regional Franciscan St. Francis Health Froedtert Memorial Lutheran George Washington University Glenbrook Glendale Adventist Glens Falls Good Samaritan Grant Medical Hackensack University Hanover Harlingen Medical Harrisburg Hartford Health Central Hennepin County Medical Center Henry Ford Henry Ford Macomb Henry Ford West Bloomfield Henry Ford Wyandotte Highland Park Hillcrest of Central Connecticut* of the University of Pennsylvania Houston Medical Howard Memorial Huntsville Indian Path Medical Center Indian River Medical Center Indiana Orthopaedic Inova Mount Vernon Issaquah Campus* Johnson City Medical Center Johnston Memorial Kadlec Regional Medical Kansas City Orthopaedic Institute* Keck of USC Kenmore Mercy Kosciusko Community Lakeland Regional Health System* Lakeview Medical Lakewood Lancaster General Largo Lutheran - Cleveland Lutheran - Fort Wayne Maine Joint Replacement Major Marshall Health Marshalltown Medical and Surgical Martha Jefferson Marymount Massachusetts General Maury Regional Medical McLaren Flint* McLaren Greater Lansing and McLaren Orthopedic of the Rockies* American Joint Replacement Registry 2014 Annual Report 31

Medina MedStar Union Memorial Memorial Hermann Memorial City Medical Memorial Hermann Southwest Memorial - Neillsville* Memorial - Springfield* Mercy Fitzgerald Mercy of Buffalo Mercy Springfield* Mercy Medical Mercy - West Lakes* Mercy Philadelphia Mercy Regional Medical Mercy Suburban Meriter - UnityPoint Health* Meritus Medical Methodist MidMichigan Medical Center - Midland MidState Midwest Orthopedic Specialty Mission Monroe Clinic* Montefiore Medical Morristown Medical Mount Carmel New Albany* MountainView Regional Medical Munson Healthcare Cadillac Munson Medical Nazareth Nebraska Medicine* Nebraska Orthopaedic New England Baptist New London Family Medical New York Methodist Newton Medical Nix Health* North Mississippi Medical Center NorthBay NorthBay VacaValley Northeast Corporation* Northern of Surry County* Northwest Medical Northwestern Medicine Central DuPage Northwestern Medicine Delnor Northwestern Memorial Novant Health Brunswick Novant Health Charlotte Orthopaedic Novant Health Forsyth Medical Novant Health Franklin Novant Health Gaffney Novant Health Huntersville Medical Center Novant Health Kernersville Medical Center Novant Health Matthews Novant Health Prince William Novant Health Rowan Novant Health Thomasville Medical Center NYU - for Joint Disease* Oasis Health Ocean Springs Ochsner - Baptist* Ochsner - Kenner* Ochsner - Main Campus * Ochsner - West Bank * OrthoCarolina Orthopaedic & Spine Specialists* Orthopaedic of Wisconsin* Pali Momi Medical Palmetto Health Baptist* Palmetto Health Baptist Parkridge Palmetto Health Richland* Park Nicollet Methodist Park Ridge Health Penn Presbyterian Penn State Milton S. Hershey Medical Pennsylvania Physicians Regional Pomona Valley Medical Poudre Valley Presbyterian Healthcare Services Providence Alaska Medical Providence Centralia Providence Holy Cross Medical Providence Holy Family Providence Hood River Memorial Providence Kodiak Island Medical Providence Little Company of Mary San Pedro* Providence Little Company of Mary Torrance* Providence Medford Medical Providence Milwaukie Providence Mount Carmel Providence Newberg Providence Portland Medical Providence Regional Everett - Colby* Providence Regional Everett - Pacific* Providence Sacred Heart Medical Providence Saint John s Health Providence Saint Joseph - Burbank* Providence Saint Joseph - Chewelah* Providence Saint Joseph - Polson* Providence Saint Mary* Providence Saint Patrick Providence Saint Peter Providence Seaside Providence St. Vincent Medical Providence Tarzana Medical Providence Willamette Falls Medical Quincy Medical Reading Redmond Regional Medical Renown Regional Medical River Oaks Riverside Medical Riverwood Healthcare Center Rockford Memorial Rockingham Memorial Ronald Reagan UCLA Medical Roper Roper St. Francis Mount Pleasant Rush University Medical Rutland Regional Medical Saint Mary s Regional San Antonio Community San Joaquin Community Sanford - Fargo* Sanford USD Medical Schneck Medical Scott & White Memorial Selby General Sentara CarePlex Sentara Leigh Sentara Norfolk General Sentara Northern Virginia Medical Sentara Obici Sentara Princess Anne Sentara Virginia Beach General Sentara Williamsburg Regional Medical Sharp Chula Vista Medical Center Sharp Coronado Sharp Grossmont Sharp Memorial Shawano Medical Simi Valley 32 American Joint Replacement Registry 2014 Annual Report

Sinai of Baltimore Singing River Sisters of Charity - Buffalo Sisters of Charity - St. Joseph Campus Skokie Sonora Regional Medical Center South County South Pointe Southeast Georgia Health System* Southwest General Health Center Sparrow Spencer St. Alphonsus Medical Center - Baker City* St. Alphonsus Medical Center - Nampa* St. Alphonsus Medical Center - Ontario* St. Alphonsus Regional Medical St. Charles Health System* St. Dominic St. Francis & (CT Joint Replacement Institute)* St. Helena St. John s - Maplewood* St. John s - Springfield St. John s - Jackson* St. John s - Westlake St. Joseph - Fort Wayne St. Joseph - St. Paul* St. Joseph Regional Health St. Joseph s Community of West Bend* St. Luke s Boise Medical St. Luke s St. Mary s and Regional Medical St. Peter s St. Vincent s Clay County St. Vincent s Medical St. Vincent s Medical Center Riverside St. Vincent s Medical Center Southside Stanford & Clinics* Steward Holy Family Stillwater Medical Stormont - Vail Healthcare* Straub Clinic and Texas Health Harris Methodist Southwest Fort Worth* Texas Health Presbyterian Plano* Texas Spine and Joint The Orthopedic The Valley Theda Clark Medical Thomas Jefferson Tillamook General Torrance Memorial Medical UCLA - Santa Monica* UCSF UH Regional s - Bedford Campus UH Regional s - Richmond Campus Ukiah Valley Medical Center Unity UnityPoint Health - Allen UnityPoint Health - St. Luke s University s Ahuja University s Case University s Conneaut University s Elyria University s Geauga University s Geneva University s Parma University of Arizona - University Campus* University of Colorado University of Iowa s and Clinics* University of Kansas Medical University of Maryland Baltimore Washington University of Maryland Charles Regional Medical Center University of Maryland Harford Memorial University of Maryland University of Maryland Midtown Campus University of Maryland Rehabilitation and Orthopaedic Institute University of Maryland Shore at Easton University of Maryland St. Joseph Medical University of Maryland Upper Chesapeake University of Michigan Health System* University of Mississippi Medical University of Texas Southwestern Medical University of Utah* University of Vermont University of Wisconsin and Clinics* UP Health System - Marquette* Vadnais Heights Surgery Valley Medical Virginia Virginia Mason Medical Virtua Marlton Virtua Memorial Virtua Voorhees* Walla Walla General WellSpan Gettysburg WellSpan Surgery and Rehabilitation WellSpan York WellStar Cobb WellStar Douglas WellStar Kennestone WellStar Paulding Wesley Medical West Shore Western Maryland Health System* Wexner at The Ohio State University White Memorial Medical Center Wilcox Memorial Winthrop-University Woodwinds WVU Healthcare Ruby Memorial American Joint Replacement Registry 2014 Annual Report 33

Appendix D ICD-9 Diagnosis Code Categories included for Hips 170.6 - Malignant neoplasm of pelvic bones, sacrum, and coccyx 170.7 - Malignant neoplasm of long bones of lower limb 198.5 - Secondary malignant neoplasm of bone 203.00 - Multiple myeloma, without mention of having achieved remission 238 - Neoplasm of uncertain behavior of other and unspecified sites and tissues 275.49 - Other disorders of calcium metabolism 369.9 - Unspecified visual loss 38.42 - Resection of vessel with replacement, other vessels of head and neck convert 38.9 - Puncture Of Vessel 428.3 - Diastolic heart failure 585.6 - End stage renal disease 696 - Psoriasis and similar disorders 710 - Arthropathies And Related Disorders - Diffuse diseases of connective tissue 711.05 - Pyogenic arthritis, pelvic region and thigh 711.95 - Unspecified infective arthritis, pelvic region and thigh Code 714 - Rheumatoid arthritis and other inflammatory polyarthropathies 714 - Rheumatoid arthritis and other inflammatory polyarthropathies 714.0 - Rheumatoid arthritis 714.00 - Rheumatoid arthritis, unspecified 714.3 - Juvenile chronic polyarthritis 714.30 - Polyarticular juvenile rheumatoid arthritis, chronic or unspecified 714.31 - Polyarticular juvenile rheumatoid arthritis, acute 714.32 - Pauciarticular juvenile rheumatoid arthritis 714.8 - Other specified inflammatory polyarthropathies 714.9 - Unspecified inflammatory polyarthropathy Code 715 - Osteoarthrosis and allied disorders 715 - Osteoarthrosis generalized involving unspecified site 715.0 - Osteoarthrosis generalized 715.00 - Osteoarthrosis, generalized, site unspecified 715.09 - Osteoarthritis, generalized multiple sites 715.1 - Osteoarthrosis, localized, primary 715.15 - Osteoarthrosis localized primary involving pelvic region and thigh 715.16 - Osteoarthrosis, localized, primary, lower leg 715.25 - Osteoarthrosis, localized, secondary, pelvic region and thigh 715.26 - Osteoarthrosis, localized, secondary, lower leg 715.3 - Osteoarthrosis localized not specified whether primary or secondary 715.35 - Osteoarthrosis, localized, not specified whether primary or secondary, pelvic region and thigh 715.36 - Osteoarthrosis, localized, not specified whether primary or secondary, lower leg 715.8 - Osteoarthrosis involving or with more than one site but not specified as generalized 715.80 - Osteoarthrosis involving, or with mention of more than one site, but not specified as generalized, site unspecified 715.89 - Osteoarthrosis involving, or with mention of more than one site, but not specified as generalized, multiple sites 715.9 - Osteoarthrosis unspecified whether generalized or localized 715.90 - Osteoarthrosis, unspecified whether generalized or localized, site unspecified 715.95 - Osteoarthrosis, unspecified whether generalized or localized, pelvic region and thigh 715.96 - Osteoarthrosis, unspecified whether generalized or localized, lower leg Code 716 - Other and unspecified arthropathies 716.1 - Traumatic arthropathy 716.10 - Traumatic arthropathy, site unspecified 716.15 - Traumatic arthropathy, pelvic region and thigh 716.35 - Climacteric arthritis, pelvic region and thigh 716.4 - Transient arthropathy 716.95 - Arthropathy, unspecified, pelvic region and thigh Code 717- Internal derangement of knee 717.49 - Other derangement of lateral meniscus Code 718 - Articular cartilage disorder site unspecified 718.0 - Articular cartilage disorder 718.05 - Articular cartilage disorder, pelvic region and thigh 718.25 - Pathological dislocation of joint, pelvic region and thigh 718.35 - Recurrent dislocation of joint, pelvic region and thigh 718.65 - Unspecified intrapelvic protrusion of acetabulum, pelvic region and thigh 718.86 - Other joint derangement, not elsewhere classified, lower leg 718.95 - Unspecified derangement of joint, pelvic region and thigh 34 American Joint Replacement Registry 2014 Annual Report

Code 719 - Other and unspecified disorders of joint 719 - Other and unspecified disorders of joint 719.09 - Effusion of joint, multiple sites 719.45 - Pain in joint involving pelvic region and thigh 719.9 - Unspecified disorder of joint 719.95 - Unspecified disorder of joint, pelvic region and thigh Code 726 - Peripheral enthesopathies and allied syndromes 726 - Peripheral enthesopathies and allied syndromes 726.5 - Enthesopathy of hip region Code 727 - Other disorders of synovium tendon and bursa 727.00 - Synovitis and tenosynovitis, unspecified Code 729 - Rheumatism unspecified and fibrositis 729.5 - Pain in limb Code 730 - Osteomyelitis periostitis and other infections involving bone 730 - Osteomyelitis periostitis and other infections involving bone 730.1 - Chronic osteomyelitis 730.15 - Chronic osteomyelitis, pelvic region and thigh Code 732 - Osteochondropathies 732.1 - Juvenile osteochondrosis of hip and pelvis Code 733 - Other disorders of bone and cartilage 733.14 - Pathologic fracture of neck of femur 733.15 - Pathologic fracture of other specified part of femur 733.19 - Pathologic fracture of other specified site 733.4 - Aseptic necrosis of bone 733.40 - Aseptic necrosis of bone, site unspecified 733.42 - Aseptic necrosis of head and neck of femur 733.43 - Aseptic necrosis of medial femoral condyle 733.49 - Aseptic necrosis of bone, other 733.81 - Malunion of fracture 733.82 - Nonunion of fracture 733.9 - Other and unspecified disorders of bone and cartilage 733.96 - Stress fracture of femoral neck 733.97 - Stress fracture of shaft of femur Code 736 - Other acquired deformities of limbs 736.3 - Acquired deformities of hip 736.30 - Unspecified acquired deformity of hip 736.39 - Other acquired deformities of hip Code 738 - Other acquired musculoskeletal deformity 738.8 - Acquired deformity of other specified site Code 755 - Other congenital anomalies of limbs 755.63 - Other congenital deformity of hip (joint) Code 808 - Fracture of pelvis 808 - Fracture of pelvis 808.0 - Closed fracture of acetabulum 808.2 - Closed fracture of pubis Code 820 - Fracture of neck of femur 820.00 - Closed fracture of intracapsular section of neck of femur, unspecified 820.02 - Closed fracture of midcervical section of neck of femur 820.03 - Closed fracture of base of neck of femur 820.09 - Other transcervical fracture of femur closed 820.1 - Transcervical fracture open 820.2 - Pertrochanteric fracture of femur closed 820.20 - Closed fracture of trochanteric section of neck of femur 820.21 - Fracture of intertrochanteric section of femur closed 820.22 - Closed fracture of subtrochanteric section of neck of femur 820.8 - Fracture of unspecified part of neck of femur, closed 820.9 - Open fracture of unspecified part of neck of femur Code 821 - Fracture of other and unspecified parts of femur 821 - Fracture of other and unspecified parts of femur 821.0 - Fracture of shaft or unspecified part of femur closed 821.00 - Closed fracture of unspecified part of femur 821.01 - Closed fracture of shaft of femur 821.2 - Fracture of lower end of femur closed Code 996 - Complications peculiar to certain specified procedures 996 - Complications peculiar to certain specified procedures 996.4 - Mechanical complication of internal orthopedic device implant and graft 996.40 - Unspecified mechanical complication of internal orthopedic device, implant, and graft 996.41 - Mechanical loosening of prosthetic joint 996.42 - Dislocation of prosthetic joint (includes instability and subluxation of prosthetic joint) 996.43 - Broken prosthetic joint implant American Joint Replacement Registry 2014 Annual Report 35

996.44 - Peri-prosthetic fracture around prosthetic joint 996.45 - Peri-prosthetic osteolysis 996.46 - Articular bearing surface wear of prosthetic joint 996.47 - Other mechanical complication of prosthetic joint implant 996.49 - Other mechanical complication of other internal orthopaedic device, implant, and graft 996.59 - Mechanical complication due to other implant and internal device, not elsewhere classified 996.6 - Infection and inflammatory reaction due to internal prosthetic device implant and graft 996.66 - Infection and inflammatory reaction due to internal joint prosthesis 996.67 - Infection and inflammatory reaction due to other internal orthopedic device, implant, and graft 996.7 - Other complications due to internal prosthetic device, implant, and graft 996.77 - Other complications due to internal joint prosthesis 996.78 - Other complications due to other internal orthopedic device, implant, and graft 998 - Other complications of procedures not elsewhere classified Miscellaneous includes M16.2 - Osteoarthrosis, localized, secondary, pelvic region and thigh M16.9 - Osteoarthrosis, localized, not specified whether primary or secondary, pelvic region and thigh Q65.9 - Other congenital deformity of hip (joint) V54.82 - Aftercare following explantation of joint prosthesis Appendix E ICD-9 Procedure Code Categories for Hips 81.5 - Joint Replacement of Lower Extremity 81.51 - Total hip replacement 81.52 - Partial hip replacement 81.53 - Revision of hip replacement, not otherwise specified 00.7 - Other Hip Procedures 00.70 - Revision of hip replacement, both acetabular and femoral components 00.71 - Revision of hip replacement, acetabular component 00.72 - Revision of hip replacement, femoral component 00.73 - Revision of hip replacement, acetabular liner and/or femoral head only 00.74 - Hip bearing surface, metal-on-polyethylene 00.8 - Other knee and hip procedures 00.85 - Resurfacing hip, total, acetabulum and femoral head 00.86 - Resurfacing hip, partial, femoral head 00.87 - Resurfacing hip, partial, acetabulum Appendix F ICD-9 Diagnosis Code Categories for Knees 170.7 - Malignant neoplasm of long bones of lower limb 198.5 - Secondary malignant neoplasm of bone and bone marrow 38.9 - Puncture Of Vessel 585.6 - End stage renal disease 696 - Psoriasis and similar disorders 711 - Arthropathy associated with infections 711.00 - Pyogenic arthritis, site unspecified 711.06 - Pyogenic arthritis, lower leg 711.96 - Unspecified infective arthritis, lower leg Code 714- Rheumatoid arthritis and other inflammatory polyarthropathies 714 - Rheumatoid arthritis and other inflammatory polyarthropathies 714.0 - Rheumatoid arthritis 714.00 - Rheumatoid arthritis, unspecified 714.3 - Juvenile chronic polyarthritis 714.30 - Polyarticular juvenile rheumatoid arthritis, chronic or unspecified 714.89 - Other specified inflammatory polyarthropathies 714.9 - Unspecified inflammatory polyarthropathy Code 715- Osteoarthrosis and allied disorders 715 - Osteoarthrosis generalized involving unspecified site 715.0 - Osteoarthrosis generalized 715.00 - Osteoarthrosis, generalized, site unspecified 715.09 - Osteoarthritis, generalized multiple sites 715.1 - Osteoarthrosis localized primary 715.15 - Osteoarthrosis localized primary involving pelvic region and thigh 36 American Joint Replacement Registry 2014 Annual Report

715.16 - Osteoarthrosis localized primary involving lower leg 715.25 - Osteoarthrosis, localized, secondary, pelvic region and thigh 715.26 - Osteoarthrosis, localized, secondary, lower leg 715.35 - Osteoarthrosis, localized, not specified whether primary or secondary, pelvic region and thigh 715.36 - Osteoarthrosis localized not specified whether primary or secondary involving lower leg 715.8 - Osteoarthrosis involving or with more than one site but not specified as generalized and involving unspecified site 715.80 - Osteoarthrosis involving, or with mention of more than one site, but not specified as generalized, site unspecified 715.89 - Osteoarthrosis involving or with multiple sites but not specified as generalized 715.9 - Osteoarthrosis unspecified whether generalized or localized 715.90 - Osteoarthrosis, unspecified whether generalized or localized, site unspecified 715.95 - Osteoarthrosis, unspecified whether generalized or localized, pelvic region and thigh 715.96 - Osteoarthrosis unspecified whether generalized or localized involving lower leg Code 716- Other and unspecified arthropathies 716.16 - Traumatic arthropathy involving lower leg 716.96 - Unspecified arthropathy involving lower leg Code 717- Internal derangement of knee 717.2 - Derangement of posterior horn of medial meniscus convert 717.3 - Other and unspecified derangement of medial meniscus convert 717.4 - Derangement of lateral meniscus 717.7 - Chondromalacia of patella 717.83 - Old disruption of anterior cruciate ligament 717.9 - Unspecified internal derangement of knee Code 719- Other and unspecified disorders of joint 719.36 - Palindromic rheumatism, lower leg 719.46 - Pain in joint involving lower leg Code 738- Other acquired musculoskeletal deformity 738.8 - Acquired deformity of other specified site Code 836- Dislocation of knee 836 - Tear of medical cartilage or meniscus of knee current Code 996 - Complications peculiar to certain specified procedures 996.40 - Unspecified mechanical complication of internal orthopedic device, implant, and graft 996.41 - Mechanical loosening of prosthetic joint 996.44 - Peri-prosthetic fracture around prosthetic joint 996.46 - Articular bearing surface wear of prosthetic joint 996.49 - Other mechanical complication of other internal orthopedic device, implant, and graft 996.66 - Infection and inflammatory reaction due to internal joint prosthesis 996.7 - Other complications due to unspecified device implant and graft 996.78 - Other complications due to other internal orthopedic device, implant, and graft Appendix G ICD-9 Procedure Code Categories for Knees 81.5 - Joint Replacement of Lower Extremity 81.47 - Other repair of knee 81.54 - Total knee replacement 81.55 - Revision of knee replacement, not otherwise specified 00.8 - Other knee and hip procedures 00.80 - Revision knee replacement, total 00.81 - Revision of knee replacement, tibial component 00.82 - Revision of knee replacement, femoral component 00.83 - Revision of knee replacement, patellar component 00.84 - Revision of total knee replacement, tibial insert (liner) Code 733- Other disorders of bone and cartilage 733.4 - Aseptic necrosis of bone 733.42 - Aseptic necrosis of head and neck of femur 733.43 - Aseptic necrosis of medial femoral condyle 733.49 - Aseptic necrosis of bone, other 733.81 - Malunion of fracture 733.92 - Chondromalacia American Joint Replacement Registry 2014 Annual Report 37

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AJRR gratefully acknowledges the assistance of Bryan D. Springer, MD, current Chair of the Data Management Committee, and the rest of the 2015 Data Committee for their direction regarding the development of the 2014 Annual Report. Members of the 2015 Data Committee include: John W. Barrington, MD; Craig J. Della Valle, MD; Michael P. Dohm, MD; Blair Fraser; Stephen E. Graves, MD; Brian R. Hallstrom, MD; Richard E. Hughes, PhD; Richard L. Illgen II, MD; Robert L. Krebbs; Hilal Maradit-Kremers, MD; David G. Mekemson; Colin Nelson; Pamela L. Plouhar, PhD; Sarah Shi; Scott M. Sporer, MD; and Jing Xie, PhD. Published by American Joint Replacement Registry 9400 West Higgins Road, Suite 210 Rosemont, IL 60018-4975 Phone: 1-847-292-0530 Email: info@ajrr.net www.ajrr.net Executive Director Jeffrey P. Knezovich, CAE Medical Director David G. Lewallen, MD* Analytics Caryn D. Etkin, PhD, MPH, Director of Analytics September R. Cahue, MPH, Senior Registry Analyst Information Technology Randolph R. Meinzer, Director of Information Technology Jillian Bachelor, IT Data Technician Kristine F. Baldwin, MS, Data Submission Analyst Steve Hamada, Senior Software Engineer Marketing and Communications Lori Boukas, MS, Director of Marketing and Communications Philip J. Dwyer, Program Coordinator Savana M. Martin, Program Coordinator Erik Michalesko, Marketing and Communications Specialist Government Relations Judi Buckalew, RN, BSN, MPH, Government Relations Specialist* Marisol Goss, Clinical Data Registry Policy and Advocacy Coordinator* * Denotes part-time/contract staff The material presented in AJRR s 2014 Annual Report has been made available by the American Joint Replacement Registry for educational purposes only. This material is not intended to present the only, or necessarily best, methods or procedures for the medical situations discussed, but rather is intended to represent an approach, view, statement, or opinion of the author(s) or producer(s), which may be helpful to others who face similar situations. Any statements about commercial products and devices do not represent an AJRR endorsement or evaluation of these products. These statements may not be used in advertising or for any commercial purpose. 2015 All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher.

American Joint Replacement Registry 9400 West Higgins Road, Suite 210 Rosemont, IL 60018-4975 Phone: 847-292-0530 Fax: 847-292-0531 Email: info@jrr.net www.ajrr.net At the time of Publication, every effort was made to ensure the information contained in this report was accurate. The document is available for download on the AJRR website. 2015 All Rights Reserved 40 American Joint Replacement Registry 2014 Annual Report