Signature Hip Technology

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1 Signature Hip Technology Personalized Patient Care

2 One Surgeon. One Patient. Over 1 million times per year, Biomet helps one surgeon provide personalized care to one patient. The science and art of medical care is to provide the right solution for each individual patient. This requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation. At Biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it s meant for a family member. Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant. When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled.

3 Signature Hip Technology Personalized Patient Care Signature Acetabular Technology allows the surgeon to accurately position cup placement based on the patient s unique anatomy. Preoperative planning software Based on MRI technology Visual guide Not dependent on patient position Problem: 50% of acetabular cup placement is outside the acceptable range for both abduction and version. 1 Despite many techniques of stabilizing and positioning the patient s pelvis, most surgeons admit that it is difficult to know precisely how the patient s pelvis is orientated during surgery. 4 Acetabular component orientation is a significant factor in the short term and long term outcomes of total hip arthroplasty (THA). 4 Improper orientation negatively impacts dislocation rates, component impingement, bearing surface wear, survivorship, and revisions in the long term. 5-8 Instability/dislocation was the most common reason for acetabular revision (33.0%) 2 Survivorship and complications have been shown to be directly related to component 9, 10 positioning during THA. Solution: Signature Acetabular Technology allows the surgeon to accurately position cup placement based on the patient s unique anatomy.

4 Signature Hip Technology The Signature Workflow Plan The Signature Planning Software utilizes MRI imaging to provide a consistent three-dimensional data set and visualization of the patient s anatomy to enhance efficiency. The intuitive layout of the software provides a multitude of preoperative visualization options to fine-tune implant size and position and generate Signature positioning guides. Position Bone models, available for each case, represent the patient s distinct acetabular anatomy and provide the following preoperative and intraoperative features: Bone landmarks identified on model Guide registration lines (representing correct guide orientation in the acetabulum) Intuitive user interface and functionality Implant library to meet surgeons implant preferences Transparent bone and/or implant views Allows for fine-tuning of cup implant sizing and positioning Surgeon-approved plan values dictate positioning guide design Rolling motions of the pelvis forward or backward can easily occur in lateral decubitus positioning, and can directly lead to undesirable variances in cup anteversion. 11 *All figures shown are for a right hip Preoperative planning is of significant value for the successful performance of THR. 13

5 Pin Pins are placed using the patient-specific guides to register the preoperative plan to the patient. Selective Laser Sintered manufacturing optimizes patient-specific guide configuration and fit Bone models accompany positioning guides for preoperative surgeon evaluation and intraoperative verification Such intraoperative pelvic motion has been reported to be one of the critical factors in poor acetabular component orientation using manual technique. 11 Place The Signature acetabular guides are designed and produced to replicate the preoperative surgical plan. Final component orientation and placement can be determined intraoperatively. Incorporation of standard instrumentation for intraoperative visualization to the Signature alignment pin

6 Signature Hip Technology System Competencies Signature Online Management System The Signature Online Management system is the comprehensive Signature case management site. Case management Imaging center interface Imaging protocols and reference tools Process status Surgeon planning preferences Access to Signature Planning Suite case plans Economic Cost of Revision Hip Surgery Signature allows the surgeon to place the cup based on the patient s unique anatomy. Revision total hip replacement surgeries impose a burden on the heath care system costing the system over one billion dollars annually. 25 With revision surgery frequently come additional complications further associated with worse functional The acetabular component orientation placed by the surgeon during total hip arthroplasty has critically important effects on dislocation, range of motion and polyethylene wear. 4 Survivorship and complications have been shown to be directly outcomes than a primary total hip replacement. 25 related to component positioning. 9-10

7 RingLoc + Acetabular Shells Locking mechanism provides low micromotion and unparalleled push-out/lever-out forces 2,3 *** Un-lock/re-lock feature allows for easy disassembly without damaging liner** Extended rim to prevent soft tissue entrapment between liner and shell Designed to accommodate E1 Antioxidant Infused and Arcom /Arcom XL polyethylene liners Active Articulation Dual Mobility Hip System The Active Articulation E1 Hip System defines the next generation of dual mobility constructs as it is specifically indicated for patients at risk for dislocation 8 and the only dual mobility system to utilize Antioxidant Infused Technology. Dislocation Resistance Ultra-Low Wear - 95% less wear than traditional THA, even when cup is at 60 degrees inclination 7 ** Large Range of Motion - Provides up to 165 degrees 7 Oxidative Stability - E1 Antioxidant Infused Technology prevents oxidative degradation of polyethylene. 9 Clinically Proven Cup 10 - The fully-hemispheric M 2 a-magnum cup contains clinically proven PPS coating 11 and fins to provide fixation and stability E1 Antioxidant Infused Technology E1 Antioxidant Infused Technology is the only bearing option that utilizes a proprietary diffusion process to maximize strength, wear resistance and prevent oxidative degradation of the polyethylene.* Biomet pioneered the first and only antioxidant infused hip, knee and shoulder bearings that actually prevent oxidative degradation of the polyethylene.* E1 acetabular liner configurations are available to be used with large femoral heads for optimal joint stability and range of motion. Patients are presenting earlier, living longer and have higher expectations then ever before.

8 References 1. Callahan, M. et al. Risk Factors for Cup Malpositioning. The Association of Bone and Joint Surgeons. Online publication. August Bozic, K. et al. The Epidemiology of Revision Total Hip Arthroplasty in the United States. The Journal of Bone and Joint Surgery. 91A: , Moskal, J. and Capps, S., Acetabular Component Positioning in Total Hip Arthroplasty: An Evidence-Based Analysis. The Journal of Arthroplasty. Vol. 28 No. 8. December DiGioia AM, Jaramaz B, Plakseychuk AY, et al. Comparison of a Mechanical Acetabular Alignment Guide with Computer Placement of the Socket. The Journal of Arthroplasty. 2002; 17: Archbold HAP, Mockford B, Molloy D, et al. The Transverse Acetabular Ligament: An Aid to Orientation of the Acetabular Component during Primary Total Hip Replacement: a preliminary study of 1000 cases investigating post-operative stability. Journal of Bone Joint Surgery. Br 2006; Jaramaz B, DiGioia AM, Blackwell M, et al. Computer Assisted Measurement of Cup Placement in Total Hip Replacement. Clin Orthop Rel Res 1998; 354: Malik A, Maheshwari A, Dorr LD. Impingement with Total Hip Replacement. Journal of Bone and Joint Surgery. Am 2007; 89: Wan Z, Boutary M, Dorr LD. The Influence of Acetabular Component Position on Wear in Total Hip Arthroplasty. Journal of Arthroplasty. 2008; 23: Sugano N, et al. Mid-term Results of Cementless Total Hip Replacement using a Ceramic on Ceramic Bearing with and without Computer Navigation. Journal of Bone and Joint Surgery. Br 2007; 89: Callaghan JJ, et al. Implant Wear Symposium 2007 Clinical Work Group: How have alternative bearings (such as metal-on-metal, highly cross-linked polyethylene, and ceramic-on-ceramic) affected the prevention and treatment of osteolysis? Journal of American Academy of Orthopedic Surgeons. 2008; 16 (suppl 1): S33-S Asayama, I et al. Intraoperative Pelvic Motion in Total Hip Arthroplasty. The Journal of Arthroplasty. Vol. 19 No. 8 December DiGioia AM, Jaramaz B, Blackwell M, et al. The Otto Aufranc Award; image guided navigation system to measure intraoperatively acetabular implant alignment. Clin Orthop Relat Res 1998; 355: Egglie, S. et. al. The value of preoperative planning for total hip arthroplasty. The Journal of Bone and Joint Surgery. Br. Vol 80-B No 3 May Millennium Research Group. US markets for large-joint reconstructive implants, Graver R. et al. The Total "Economic Cost" of Revision Total Joint Replacement Surgery in the United States. Online publication. March Kim S. Changes in surgical loads and economic burden of hip and knee replacement in the US: Arthritis Rheum 2008 Apr 15; 59 (4): Kurtz, S. et. al. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to Journal of Bone and Joint Surgery. AM 2007 Apr; 89 (4); Kurtz, S., et al. The UHMWPE Handbook: Ultra High Molecular Weight Polyethylene in Total Joint Replacement. (2nd ed.). Elsevier Academic Press. San Diego, CA. 2004,pp Tower, et al. Rim Cracking of the Cross-Linked Longevity Polyethylene Acetabular Liner After Total Hip Arthroplasty. The Journal of Bone and Joint Surgery. 89:2212-7, Currier, B., et al. In Vivo Oxidation in Remelted Highly Cross-Linked Retrievals. The Journal of Bone & Joint Surgery. 92: , Wannomae, K., et al. Persistent Free Radicals in X3 UHMWPE. Advances in Arthroplasty Course. Cambridge, MA: Muratoglu, O., et al. Ex Vivo Stability Loss of Irradiated and Melted Ultra-High Molecular Weight Polyethylene. Journal of Bone and Joint Surgery. 92: , Data on file at Biomet. Bench test results are not necessarily indicative of clinical performance. 24. Nabar, S., et al. Comparison of Second Generation Highly Crosslinked Polyethylenes Under Adverse Aging Conditions.ORS Poster No Katz J. et al. Failures of Total Hip Replacement: A Population-Based Perspective. The Orthopaedic Journal at Harvard Medical School * FDA cleared claim. See biomet.com/e1 for complete claim language. ** Laboratory testing is not necessarily indicative of clinical performance. ***Any time the liner is removed, it is recommended that the locking ring be removed and replaced with a new one. If the liner is damaged in any way, a new liner should be utilized. All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the Biomet Sales force and physicians only and is NOT intended for patient distribution. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and Biomet s website. Responsible Manufacturer Biomet, Inc. P.O. Box E. Bell Drive Warsaw, Indiana USA 2013 Biomet Orthopedics Form No. BMET REV

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