ReCap Product Rationale - Biomet UK

1 Biomet UK LtdWaterton Industrial EstateBridgend, South WalesCF31 3XA, United KingdomTel. +44 (0)1656 655221 Fax. +44 (0)1656 645454 FLH 155 01/09 ReCapProduct Rationale ReCapProduct Rationale A complete resurfacing system designed on sound engineering principles, tried and tested materials and clinically proven fixation methodsBone PreservationOptimal Wear Characteristics/TribologyClinically Proven Fixation MethodsIntra Operative FlexibilityPrecise & Reproducible InstrumentationAccumulated 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.

2 The time has come when the use of Metal on Metal bearings, with virtually no generation of wear debris, should be considered in such 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 M2a Hip response to this Biomet , alongside Key Development Centres world-wide, have developed the ReCap Total Resurfacing Wall Thickness -Greater bone preservationHemispherical Shell Design -Maximises head coveragewhilst providing a secure press fitPorous Plasma Spray (PPS) -Twice the rotational stability of beads and clinically proven as a bone friendly in-growth surface1-4(HA Coated Options also available).

3 Anti Rotational Fins -Additional primary fixation Large Implant Range - 44mm 68mmin 2 mm incrementsOversized Shell Options (+2mm) - Addresses femoral and acetabular mismatchIntroduction 1. Bourne, et al.: Titanium Porous Plasma Spray Coating. CORR, No. 298, January 1994. 2. Burt, ; et al.: A Femoral Component Inserted Without Cement in Total Hip Arthroplasty. JBJS, July 1998. 3. Coathup, ; 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, ; et al.: Initial Scratch Fit Stability of Acetabular Cups: Comparison of Three Porous Coating Systems.

4 ISTA, San Diego, CA, degrees Head Coverage -Allowing greater range of motionUnique Internal Spherical Geometry -Allowing for more natural femoral loading patterns Interlok Surface -Clinically proven cemented surface The ReCap SystemLarge Implant Range -12 sizes (38mm-60mm) 2mm Increments M2a Precision Manufacture -100 % checked by Zygo Machine, note Tolerance levels as cast cobalt chrome headBone PreservationThe 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: Reduces Risk of Notching Normal Femoral Loading Restoration of Normal Anatomy Reduced Risk of DislocationThe acetabular component is no different.

5 With a wall thickness of only 3mm and again a 2mm increment component sizing, it allows minimal reaming to achieve optimal Wear Characteristics and TribologyBiomet 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, Metcalf, Jones, Band and Skupien, Wear 255 (2003), 999-1006 Clinically Proven Fixation MethodsIn determining which implant and surface coating is best for patients, many issues should be considered, including: How are initial stability and fixation achieved?

6 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 Stem: Survivorship 12 years2 100% Survivorship years3 taperloc Stem: Survivorship 12 years4 98% Survivorship 12 Years5 1.

7 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 FlexibilityIn 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.

8 Large Implant Range38mm-60mm Femoral Head 2mm Increments44mm-66mm Acetabular Cup 2mm IncrementsModular Revision HeadsDesigned for easy revision to be used with any Biomet Stem2mm Oversized Acetabular CupsOversized Outer Diameter of acetabular shell To offer femoral and acetabular size Coating & HA CoatingFemoral and Acetabular Components available as cemented or uncemented with & Reproducable InstrumentationDedicated Instrumentation Machined to exact tolerances enabling reproducible results time after Surgical TechniqueLogical stepped surgical procedure giving the surgeon intra operative flexibilityReliable, Accuracy, Advanced SimplicityThe validated KS alignment device is an efficient reproducible and reliable1,2 tool which makes femoral pin positioning easyDesigned to be used with MicroPlastyInstruments designed to be used through a minimal incision, allowing Rapid Recovery for the patient.

9 1. Validation of Femoral Resurfacing alignment device using computer aided navigation A Phadnis*, K Singhal, V Pitk nen, A Turner, Poster presented at the Biomet Hip Symposium 20062. Femoral Resurfacing Component position using an alignment device vs CAN A Phadnis*, K Singhal, V Pitk nen, A Turner Implants Cat. No. Description 157844 ReCap PF PC Acetabular Comp 44/38mm 157846 ReCap PF PC Acetabular Comp 46/40mm 157848 ReCap PF PC Acetabular Comp 48/42mm 157850 ReCap PF PC Acetabular Comp 50/44mm 157852 ReCap PF PC Acetabular Comp 52/46mm 157854 ReCap PF PC Acetabular Comp 54/48mm 157856 ReCap PF PC Acetabular Comp 56/50mm 157858 ReCap PF PC Acetabular Comp 58/52mm 157860 ReCap PF PC Acetabular Comp 60/54mm 157862 ReCap PF PC Acetabular Comp 62/56mm 157864 ReCap PF PC Acetabular Comp 64/58mm 157866 ReCap PF PC Acetabular Comp 66/60mmReCap Porous Coated Acetabular Components

10 Cat. No. Description 157944 ReCap PF HA/PC Acetabular Comp 44/38mm 157946 ReCap PF HA/PC Acetabular Comp 46/40mm 157948 ReCap PF HA/PC Acetabular Comp 48/42mm 157950 ReCap PF HA/PC Acetabular Comp 50/44mm 157952 ReCap PF HA/PC Acetabular Comp 52/46mm 157954 ReCap PF HA/PC Acetabular Comp 54/48mm 157956 ReCap PF HA/PC Acetabular Comp 56/50mm 157958 ReCap PF HA/PC Acetabular Comp 58/52mm 157960 ReCap PF HA/PC Acetabular Comp 60/54mm 157962 ReCap PF HA/PC Acetabular Comp 62/56mm 157964 ReCap PF HA/PC Acetabular Comp 64/58mm 157966 ReCap PF HA/PC Acetabular Comp 66/60mmReCap