ReCap Product Rationale

Similar documents
M 2 a-magnum. Design Rationale. Large Metal Articulation. Knees Hips Extremities Cement and Accessories PMI. Technology

Metasul LDH Large Diameter Head

BONE PRESERVATION STEM

Acetabular Wedge Augment System

The Right Choice. Exeter. total hip system

Why an Exactech Hip is Right for You

Accolade. System. Brochure. Achieving Perfect Balance. Cemented and Cementless Femoral Hip System

Clinically Proven Fiber Metal Material. Power to choose advanced bearing technologies to match patient demands

Taperloc Complete Hip System

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Health Technology Appraisal

Answers to commonly asked questions from patients with metal-on-metal hip replacements / resurfacings. Contents

.URGENT DEVICE CORRECTION

frequently asked questions Knee and Hip Joint Replacement Technology

Total Hip Joint Replacement. A Patient s Guide

ABGII Cement Free Total Hip Replacement System

TOTAL HIP REPLACEMENT FOR A LIFETIME: THE CEMENTLESS METAL ON METAL RECONSTRUCTION

Metal-on-Metal Hip Systems

on-metal Hips: Device Mechanics and Failure Modes

P REPLACEMENT SURGERY

High-Flex Solutions for the MIS Era. Zimmer Unicompartmental High Flex Knee System

Exeter. Surgical Technique. V40 Stem Cement-in-Cement. Orthopaedics

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology

Modular Dual Mobility Acetabular Components: An Important Extension of a Proven Approach to Hip Instability


Medical Device Alert. Device All metal-on-metal (MoM) hip replacements. Action by. CAS deadlines. Ref: MDA/2012/036 Issued: 25 June 2012 at 11:00

Design surgeon list. Smith & Nephew thanks the following surgeons for their participation as part of the R3 system design team:

DRAFT. Triathlon TS Knee System. Surgical Protocol. Version 1

YOUR GUIDE TO TOTAL HIP REPLACEMENT

Simplified surgery. Personalized performance.

Restoration Modular Cone Body/Conical Distal Stem Femoral Components Using the Restoration Modular Instrument System Surgical Technique

Exeter X3 RimFit. Acetabular Cup Surgical Protocol

Restoration Modular. Revision Hip System Surgical Protocol

VERSYS HERITAGE CDH HIP PROSTHESIS. Surgical Technique for CDH Hip Arthroplasty

Hip Resurfacing 2011 ORIGINAL ARTICLE. James W. Pritchett MD. Introduction. Abstract

Graphic courtesy of DePuy Orthopaedics, Inc. HealthEast Joint Replacement Registry: 20 Year Report

Surgical technique. Sagitta EVL

Randal S. Ford. ATTORNEY AT LAW (205) DePuy ASR Hip Implant Recall Fact Sheet

PROCOTYL L. Acetabular Cup System

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

A Magazine Dedicated to Mass Torts Law. The Dangers of Metal-on-Metal Hips. Details of DePuy ASR Settlement Announced.

Zimmer M/L Taper Hip Prosthesis. Surgical Technique

Rejuvenate Total Hip System Surgical Protocol. Rejuvenate Modular Hip Stem Enhanced Stability 1 Proven Modularity 2 Intraoperative Flexibility

Disclosures. ! Consultant. ! Stryker. ! Smith and Nephew. Why Resurface? ! Save bone the day of surgery. ! No bone loss from stressshielding

ACCOLADE II. Orthopaedics. Femoral Hip System. Surgical Technique

An Alternative Conservative Approach to Hip Reconstruction

METAL HEMI. Great Toe Implant SURGICAL TECHNIQUE

Oxford Partial Knee. A Definitive Implant. Tibial Component. Anatomical shape for optimal bone coverage

VERILAST Technology for Hip Replacement Implants

MDMTM. Surgical Technique. Modular Dual Mobility TM Acetabular System. Orthopaedics

Think precision, Think HSS REAMING

Posterior Referencing. Surgical Technique

The information contained in this document is intended for healthcare professionals only.

IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA

Minimally Invasive Hip Replacement through the Direct Lateral Approach

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology. Surgical Technique

Zimmer FuZion Instruments. Surgical Technique (Beta Version)

TOTAL HIP REPLACEMENT: MODERN SURGERY FOR SEVERE ARTHRITIS OF THE HIP

MDM. Surgical Technique. Modular Dual Mobility Acetabular System. Orthopaedics

Introduction to the Bertram Hip Spacer

Y O U R S U R G E O N S. choice of. implants F O R Y O U R S U R G E R Y

Surgical procedure. METS Modular Distal Femur

PERIPROSTHETIC IMPLANTS

Implant Systems MAX LOGIC MONO. Today s name in tomorrow s implant technology

Contact: Steve Hurson VP, R & D Nobel Biocare Savi Ranch Pkwy Yorba Linda, CA (714) steve.hurson@nobelbiocare.

Prostalac Hip System. Surgical Technique

Wear-contact analysis of hip implant coated with functionally graded material

How To Use A Phoenix Retrograde Femoral Nail

Research Letter Biomimetic Composite-Metal Hip Resurfacing Implant

Zimmer Segmental System. Distal Femoral Surgical Technique

14 Metallic Alloys in Total Hip Arthroplasty

Aesculap Orthopaedics BiCONTACT

Clinical Testing for Metal-on-Metal Prosthetic Wear and Tear

IN THE FEDERAL COURT OF AUSTRALIA (FCA) NEW SOUTH WALES REGISTRY - FEDERAL COURT OF AUSTRALIA

it s time for rubber to meet the road

The information contained in this document is intended for healthcare professionals only.

Failure Mechanisms and Closed Reduction of a Constrained Tripolar Acetabular Liner

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

AN AUTOMATED SIZE RECOGNITION TECHNIQUE FOR ACETABULAR IMPLANT IN TOTAL HIP REPLACEMENT

Summary of Safety and Effectiveness

The Journal of Arthroplasty

PINNACLE. Polyethylene Surgical Technique. Surgical Technique

Bringing together proven technologies. Zimmer Continuum Acetabular System

UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA APPLICABILITY OF ORDER. 1. This Order applies to all individual personal injury Complaints filed by

BIRMINGHAM HIP Resurfacing (BHR ) System PATIENT INFORMATION

Validation of biomedical coatings

HEADER TOTAL HIP REPLACEMENT SURGERY FROM PREPARATION TO RECOVERY

Tube Control Measurement, Sorting Modular System for Glass Tube

Zimmer MOST Options System

Technical Data. 7. Bearing Fits. 7.1 Interference. 7.2 Calculation of interference F B LLLLLLLLL( A-54

EBM Inside. Additive Manufacturing of orthopedic implants

S-ROM NOILES. This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE

Photograph showing the components of an artificial total hip

(English) NEXUS SPINE SPACER SYSTEM

From Department of Orthopaedics, Conquest Hospital, The Ridge, East Sussex. n N.A. Sandiford, FRCS (Tr/Orth), MFSEM, Specialist. Registrar.

MediPoint: Total Hip Replacement - US Analysis and Market Forecasts

Transcription:

FLH 155 01/09 Biomet UK Ltd Waterton Industrial Estate Bridgend, South Wales CF31 3XA, United Kingdom Tel. +44 (0)1656 655221 Fax. +44 (0)1656 645454

ReCap Product Rationale

A complete resurfacing system designed on sound engineering principles, tried and tested materials and clinically proven fixation methods

Bone Preservation Optimal Wear Characteristics/Tribology Clinically Proven Fixation Methods Intra Operative Flexibility Precise & Reproducible Instrumentation

Anti Rotational Fins - Additional primary fixation 3mm Wall Thickness - Greater bone preservation Porous Plasma Spray (PPS) - Twice the rotational stability of beads and clinically proven as a bone friendly in-growth surface 1-4 (HA Coated Options also available). Oversized Shell Options (+2mm) - Addresses femoral and acetabular mismatch Hemispherical Shell Design - Maximises head coverage whilst providing a secure press fit Large Implant Range - 44mm 68mm in 2 mm increments Introduction Accumulated experience has shown that wear particles of polyethylene are the principle cause of interface failure. This is particularly important in young, high activity individuals where long term fixation is needed. The time has come when the use of Metal on Metal bearings, with virtually no generation of wear debris, should be considered in such patients. Biomet s commitment to manufacturing Gold Standard Metal on Metal implants date back to 1961 with Stanmore Total Hip System. This was followed by the McKee Farrar Total Hip System and more recently with the M 2 a Hip System. In response to this Biomet, alongside Key Development Centres world-wide, have developed the ReCap Total Resurfacing System. 1. Bourne, et al.: Titanium Porous Plasma Spray Coating. CORR, No. 298, January 1994. 2. Burt, C.F; et al.: A Femoral Component Inserted Without Cement in Total Hip Arthroplasty. JBJS, July 1998. 3. Coathup, M.J.; et al.: A Comparison of Bone Remodeling Around Hydroxyapatite Coated, Porous-Coated and Grit-Blasted Hip Replacements Retrieved at Post- Mortem. JBJS, January 2001. 4. Markel, D.C.; et al.: Initial Scratch Fit Stability of Acetabular Cups: Comparison of Three Porous Coating Systems. ISTA, San Diego, CA, 1997.

The ReCap System M2a Precision Manufacture - 100 % checked by Zygo Machine, note Tolerance levels as cast cobalt chrome head 23 degrees Head Coverage - Allowing greater range of motion Unique Internal Spherical Geometry - Allowing for more natural femoral loading patterns Interlok Surface - Clinically proven cemented surface Large Implant Range - 12 sizes (38mm-60mm) 2mm Increments Bone Preservation The ReCap Total Resurfacing System resects minimal bone both from the femur and acetabulum. This is attributed to the thin components and 2mm increment component sizing. The unique spherical femoral reaming technique employed by the system, offers some distinct advantages: The acetabular component is no different. With a wall thickness of only 3mm and again a 2mm increment component sizing, it allows minimal reaming to achieve optimal fixation. Reduces Risk of Notching Normal Femoral Loading Restoration of Normal Anatomy Reduced Risk of Dislocation

Optimal Wear Characteristics and Tribology Biomet had a vast understanding of what is needed to produce the optimal Metal on Metal Implant, focusing efforts on optimal materials, manufacturing tolerances and processes. As-cast materials were determined to have greater abrasive wear resistance when compared to single or multiple heat treated materials A tribological study of cobalt chromium molybdenum alloys used in metal-on-metal resurfacing hip arthroplasty, J. Cawley, J.E.P. Metcalf, A.H. Jones, T.J. Band and D.S. Skupien, Wear 255 (2003), 999-1006

Clinically Proven Fixation Methods In determining which implant and surface coating is best for patients, many issues should be considered, including: How are initial stability and fixation achieved? To what degree will osseointegration occur, and when? Will the coating successfully inhibit debris migration? By addressing these three critical issues, Biomet s Porous Plasma Spray has achieved outstanding clinical results since its introduction in1981. At follow up, surgeons are observing results of nearly 100% Survivorship at over 10 years with implants such as the Bimetric Hip System, Taperloc Hip System. Hydroxyapatite increases the amount of in growth and attachment of bone, and will further aid in initial stability when applied on top of our clinically proven Porous Plasma Spray. 1 BiMetric Stem: 99.5% Survivorship 12 years 2 100% Survivorship 10.4 years 3 Taperloc Stem: 99.6% Survivorship 12 years 4 98% Survivorship 12 Years 5 1. Blunn, et. al. JBJS Vol. 83-B, No 1, January 2001 2. Eskeline et. al. Acta Orthopeadica 2006; 77 (1): 57-70 3. Meding et. al. JBJS (A) 2004;86-A: 92-97 4. McLaughlin et. al. JBJS(A) 2008;90:1290-1296 5. Parvizi et. al. Journal of Arhtroplasty 2004;19:No. 2:151-156

As-cast materials were determined to have greater abrasive wear resistance when compared to single or multiple heat treated materials Intraoperative Flexibility In an unpredictable situation like surgery, it is comforting to know you have a number of options to deal with difficult situations. ReCap is one of the most comprehensive Systems on the Market, offering: Large Implant Range 38mm-60mm Femoral Head 2mm Increments 44mm-66mm Acetabular Cup 2mm Increments Can be used with any Biomet Stem 2mm Oversized Acetabular Cups Oversized Outer Diameter of acetabular shell To offer femoral and acetabular size mismatching. Porous Coating & HA Coating Femoral and Acetabular Components available as cemented or uncemented with HA. Modular Revision Heads Designed for easy revision to THR.

Precise & Reproducable Instrumentation Dedicated Instrumentation Machined to exact tolerances enabling reproducible results time after time. Sequential Surgical Technique Logical stepped surgical procedure giving the surgeon intra operative flexibility Reliable, Accuracy, Advanced Simplicity The validated KS alignment device is an efficient reproducible and reliable 1,2 tool which makes femoral pin positioning easy Designed to be used with MicroPlasty Instruments designed to be used through a minimal incision, allowing Rapid Recovery for the patient. 1. Validation of Femoral Resurfacing alignment device using computer aided navigation A Phadnis*, K Singhal, V Pitkänen, A Turner, Poster presented at the Biomet Hip Symposium 2006 2. Femoral Resurfacing Component position using an alignment device vs CAN A Phadnis*, K Singhal, V Pitkänen, A Turner

Ordering Information Implants ReCap Resurfacing Heads ReCap Femoral Instrument Tray Catalogue Number 31-600206 Cat. No. Description 157238 ReCap Resurfacing Head Sz 38mm 157240 ReCap Resurfacing Head Sz 40mm 157242 ReCap Resurfacing Head Sz 42mm 157244 ReCap Resurfacing Head Sz 44mm 157246 ReCap Resurfacing Head Sz 46mm 157248 ReCap Resurfacing Head Sz 48mm 157250 ReCap Resurfacing Head Sz 50mm 157252 ReCap Resurfacing Head Sz 52mm 157254 ReCap Resurfacing Head Sz 54mm 157256 ReCap Resurfacing Head Sz 56mm 157258 ReCap Resurfacing Head Sz 58mm 157260 ReCap Resurfacing Head Sz 60mm ReCap HA/Porous Coated Acetabular Components ReCap General Instrument Tray Catalogue Number 31-600201 ReCap Cylindrical Reamer Tray Catalogue Number 31-600203 Cat. No. Description 157944 ReCap PF HA/PC Acetabular Comp Ø 44/38mm 157946 ReCap PF HA/PC Acetabular Comp Ø 46/40mm 157948 ReCap PF HA/PC Acetabular Comp Ø 48/42mm 157950 ReCap PF HA/PC Acetabular Comp Ø 50/44mm 157952 ReCap PF HA/PC Acetabular Comp Ø 52/46mm 157954 ReCap PF HA/PC Acetabular Comp Ø 54/48mm 157956 ReCap PF HA/PC Acetabular Comp Ø 56/50mm 157958 ReCap PF HA/PC Acetabular Comp Ø 58/52mm 157960 ReCap PF HA/PC Acetabular Comp Ø 60/54mm 157962 ReCap PF HA/PC Acetabular Comp Ø 62/56mm 157964 ReCap PF HA/PC Acetabular Comp Ø 64/58mm 157966 ReCap PF HA/PC Acetabular Comp Ø 66/60mm ReCap Spherical Reamer Tray Catalogue Number 31-600204 ReCap Impaction Instrument Tray Catalogue Number 31-600597 ReCap Porous Coated Acetabular Components Cat. No. Description 157844 ReCap PF PC Acetabular Comp Ø 44/38mm 157846 ReCap PF PC Acetabular Comp Ø 46/40mm 157848 ReCap PF PC Acetabular Comp Ø 48/42mm 157850 ReCap PF PC Acetabular Comp Ø 50/44mm 157852 ReCap PF PC Acetabular Comp Ø 52/46mm 157854 ReCap PF PC Acetabular Comp Ø 54/48mm 157856 ReCap PF PC Acetabular Comp Ø 56/50mm 157858 ReCap PF PC Acetabular Comp Ø 58/52mm 157860 ReCap PF PC Acetabular Comp Ø 60/54mm 157862 ReCap PF PC Acetabular Comp Ø 62/56mm 157864 ReCap PF PC Acetabular Comp Ø 64/58mm 157866 ReCap PF PC Acetabular Comp Ø 66/60mm ReCap Auxiliary Tray Assembly Catalogue Number 31-601075 ReCap Acetabular Grater Reamer Tray Catalogue Number 31-600055

Cementless Over-Size PC Acetabular Components Cat. No. Descriptioners 130846 ReCap OS PC Acetabular Comp 38/46mm 130848 ReCap OS PC Acetabular Comp 40/48mm 130850 ReCap OS PC Acetabular Comp 42/50mm 130852 ReCap OS PC Acetabular Comp 44/52mm 130854 ReCap OS PC Acetabular Comp 46/54mm 130856 ReCap OS PC Acetabular Comp 48/56mm 130858 ReCap OS PC Acetabular Comp 50/58mm 130860 ReCap OS PC Acetabular Comp 52/60mm 130862 ReCap OS PC Acetabular Comp 54/62mm 130864 ReCap OS PC Acetabular Comp 56/64mm 130866 ReCap OS PC Acetabular Comp 58/66mm 130868 ReCap OS PC Acetabular Comp 60/68mm Cementless Over-Size HA/PC Acetabular Components Cat. No. Descriptioners 130846HA ReCap OS HA/PC Acetabular Comp 38/46mm 130848HA ReCap OS HA/PC Acetabular Comp 40/48mm 130850HA ReCap OS HA/PC Acetabular Comp 42/50mm 130852HA ReCap OS HA/PC Acetabular Comp 44/52mm 130854HA ReCap OS HA/PC Acetabular Comp 46/54mm 130856HA ReCap OS HA/PC Acetabular Comp 48/56mm 130858HA ReCap OS HA/PC Acetabular Comp 50/58mm 130860HA ReCap OS HA/PC Acetabular Comp 52/60mm 130862HA ReCap OS HA/PC Acetabular Comp 54/62mm 130864HA ReCap OS HA/PC Acetabular Comp 56/64mm 130866HA ReCap OS HA/PC Acetabular Comp 58/66mm 130868HA ReCap OS HA/PC Acetabular Comp 60/68mm M2a-Magnum Modular Heads Cat. No. Description 157438 M2a-Magnum Modular Head Sz 38mm 157440 M2a-Magnum Modular Head Sz 40mm 157442 M2a-Magnum Modular Head Sz 42mm 157444 M2a-Magnum Modular Head Sz 44mm 157446 M2a-Magnum Modular Head Sz 46mm 157448 M2a-Magnum Modular Head Sz 48mm 157450 M2a-Magnum Modular Head Sz 50mm 157452 M2a-Magnum Modular Head Sz 52mm 157454 M2a-Magnum Modular Head Sz 54mm 157456 M2a-Magnum Modular Head Sz 56mm 157458 M2a-Magnum Modular Head Sz 58mm 157460 M2a-Magnum Modular Head Sz 60mm M2a-Magnum Modular Head 12/14 Taper Adaptors Cat. No. Descriptioners 130824 M2a-Magnum Tpr Adptr 38-40mm 2mm 12/14 130825 M2a-Magnum Tpr Adptr 38-40mm STD 12/14 130826 M2a-Magnum Tpr Adptr 38-40mm +4mm 12/14 130827 M2a-Magnum Tpr Adptr 38-40mm +8mm 12/14 130829 M2a-Magnum Tpr Adptr 42-50mm 2mm 12/14 130830 M2a-Magnum Tpr Adptr 42-50mm STD 12/14 130831 M2a-Magnum Tpr Adptr 42-50mm +4mm 12/14 130832 M2a-Magnum Tpr Adptr 42-50mm +8mm 12/14 130834 M2a-Magnum Tpr Adptr 52-60mm 2mm 12/14 130835 M2a-Magnum Tpr Adptr 52-60mm STD 12/14 130836 M2a-Magnum Tpr Adptr 52-60mm +4mm 12/14 130837 M2a-Magnum Tpr Adptr 52-60mm +8mm 12/14 M2a-Magnum Modular Head Type1 Taper Adaptors Cat. No. Description 130818 M2a-Magnum Tpr Adptr 38-40mm 6mm (T1) 130819 M2a-Magnum Tpr Adptr 38-40mm 3mm (T1) 130820 M2a-Magnum Tpr Adptr 38-40mm STD (T1) 130821 M2a-Magnum Tpr Adptr 38-40mm +3mm (T1) 130822 M2a-Magnum Tpr Adptr 38-40mm +6mm (T1) 130823 M2a-Magnum Tpr Adptr 38-40mm +9mm (T1) 139252 M2a-Magnum Tpr Adptr 42-50mm 6mm (T1) 139254 M2a-Magnum Tpr Adptr 42-50mm 3mm (T1) 139256 M2a-Magnum Tpr Adptr 42-50mm STD (T1) 139258 M2a-Magnum Tpr Adptr 42-50mm +3mm (T1) 139260 M2a-Magnum Tpr Adptr 42-50mm +6mm (T1) 139262 M2a-Magnum Tpr Adptr 42-50mm +9mm (T1) 139264 M2a-Magnum Tpr Adptr 52-60mm 6mm (T1) 139266 M2a-Magnum Tpr Adptr 52-60mm 3mm (T1) 139268 M2a-Magnum Tpr Adptr 52-60mm STD (T1) 139270 M2a-Magnum Tpr Adptr 52-60mm +3mm (T1) 139272 M2a-Magnum Tpr Adptr 52-60mm +6mm (T1) 139274 M2a-Magnum Tpr Adptr 52-60mm +9mm (T1) Instrumentation ReCap/M2a-Magnum Modular Head Tray - Catalogue Number 31-600199 (note: when ordering catalogue no. 31-600199 please also order either 31-600386 or 31-600388) M2a-Magnum Mod Head Trial Taper Adaptor Set (12-14) Catalogue Number 31-600388 M2a-Magnum Mod Head Trial Taper Adaptor Set (T1) Catalogue Number 31-600386