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Bi-Metric Total Hip System - Biomet

B i-Metric Total Hip System . P erformance proven P erformance proven Plasma Spray Porous Coating Biomet 's proprietary plasma spray application is unique in comparison to other techniques due to the fact that only the titanium powder used to create the coating is heated, not the substrate of the implant which can result in a weakened material. The porosity of the plasma spray porous surface allows for bone to penetrate and create a mechanical bond with the porous coating. The pore size of Biomet 's plasma-sprayed components falls within a 100 to 1,000 micron range, thus providing the optimal pore range for implant fixation and stability. The closed pore plasma porous spray has demonstrated excellent clinical results since 1984. Closed-Pore Open-Pore . porous coating porous coating potentially seals allows the proximal debris femur. migration. ( Biomet ) (Competition). AUTHOR REFERENCE HIP IMPLANT System YEARS FOLLOWED OSTEOLYSIS.

B i-Metric Total Hip System A Member of the Alliance Family¤ P P he Bi-Metric Total Hip System, since its introduction, continues to provide a high degree of versatility and unsurpassed clinical

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Transcription of Bi-Metric Total Hip System - Biomet

1 B i-Metric Total Hip System . P erformance proven P erformance proven Plasma Spray Porous Coating Biomet 's proprietary plasma spray application is unique in comparison to other techniques due to the fact that only the titanium powder used to create the coating is heated, not the substrate of the implant which can result in a weakened material. The porosity of the plasma spray porous surface allows for bone to penetrate and create a mechanical bond with the porous coating. The pore size of Biomet 's plasma-sprayed components falls within a 100 to 1,000 micron range, thus providing the optimal pore range for implant fixation and stability. The closed pore plasma porous spray has demonstrated excellent clinical results since 1984. Closed-Pore Open-Pore . porous coating porous coating potentially seals allows the proximal debris femur. migration. ( Biomet ) (Competition). AUTHOR REFERENCE HIP IMPLANT System YEARS FOLLOWED OSTEOLYSIS.

2 Evans and DeLee Submitted for Publication Bi-Metric ( Biomet ) 5 13 years Mauerhan, et al. J. Arthroplasty, 1997 Integral ( Biomet ) 5 8 years McLaughlin JBJS Taperloc ( Biomet ) 8 years Multi-Center Study Biomet Clinical Report 1994 Taperloc, Mallory-Head, 5 years Bi-Metric , Integral ( Biomet ). Mallory, et al. AAOS 1995 Mallory-Head ( Biomet ) years avg. follow-up Rothman Orthopedics 1994 Taperloc ( Biomet ) 7 years Capello, McClain Trans. Int'l Symposium 1992 Omnifit (Stryker) 2 6 years Heekin, et al. JBJS 1993 PCA (Howmedica) 5 7 years Woolson, Maloney J. Arthroplasty, 1992 Harris/Galante (Zimmer) years avg. follow-up Kim, et al. Orthop. Trans, 1992 93 PCA (Howmedica) 2 7 years Kim, et al. Orthop. Trans, 1992 93 AML (DePuy) 2 7 years Smith, Harris CORR, 1995 Harris/Galante (Zimmer) years avg. follow-up Engh Presentation, 1992 AML (DePuy) years avg. follow-up B i-Metric Total Hip System A Member of the Alliance Family T he Bi-Metric Total Hip System , since its introduction, continues to provide a high degree of versatility and unsurpassed clinical performance.

3 After a 5 to 13 year follow-up on the Bi-Metric Porous Primary,1 Evans and DeLee found: 0% Distal Thigh Pain 0% Distal Osteolysis 6% Stress Shielding 100% Survivorship The Bi-Metric is an essential part of the Alliance family which comprises the largest assembly of hip implants utilizing one simple, accurate and reproducible set of instruments. Designed to off-load stresses gradually from proximal to distal, all Bi-Metric components incorporate Biomet 's proven bi-planar taper geometry. The stem geometry promotes increased proximal off-loading and fills a greater portion of the metaphysis than a cylindrical, parallel sided implant. This greatly reduces the chances of proximal bone resorption and distal hypertrophy. 1. P. Evans, JA, DeLee, JC, Outcome of a Tapered, Titanium, Proximal Load-Bearing, Non-Cemented Femoral THA Component: Submitted for Publication. P. B i-Metric Primary Bi-Planar Stem Taper Provides enhanced proximal stress off-loading and initial implant stability.

4 Titanium Alloy Plasma Spray Porous Coating The coating's closed pore design acts as a potential barrier to the migration of particulate debris and provides rotational stability and proven long-term fixation. Forged Titanium Ensures biocompatibility and fatigue strength; titanium displays a lower modulus of elasticity for enhanced load transfer. Available in both collared (A) (B). and collarless designs. The Bi-Metric 's 3 tapered stem design (A) provides for excellent proximal fit and minimizes removal of distal Cemented option also available. cortical bone as compared to a straight, cylindrical design (B). PMMA distal centralizer used to prevent Modular Head Options varus or valgus stem positioning. (Available in 22, 26, 28 and 32mm Diameters). Zirconia / CoCr CoCr Zirconia The Bi-Metric Porous Primary Hip Prosthesis is marketed for noncemented use in skeletally mature patients undergoing primary hip replacement surgery as a result of noninflammatory degenerative joint disease.

5 28mm Neck 29mm Neck 31mm Neck 34mm Neck (-6) (-5) (-3) (STD). CoCr Zirconia/CoCr 37mm Neck 40mm Neck 43mm Neck 46mm Neck (+3) (+6) (+9) (+12). P P. erformance roven B. Bi-Metric Head/Neck Components i-Metric Head/Neck Bi-Planar Stem Taper Provides enhanced proximal stress off-loading and initial implant stability. Interlok Surface Interlok finish provides enhanced cement-to-implant bonding. Three Proximal Resection Levels Provide increased flexibility to conform to and match the patient's anatomy. 34mm Resection Level . 34mm Primary resection level. Resection 45mm Resection Level . Bone deficiency at the level of the lesser trochanter. 55mm Resection Level Bone deficiency below the lesser trochanter. PMMA Distal Stem Positioner (150mm and 200mm Lengths). Centralizes the stem in the distal canal to help prevent varus and valgus 45mm stem placement. Resection Available Lengths The implant is offered in 150mm and 200mm straight stems and in a 250mm bowed option for unmatched flexibility.

6 The Bi-Metric Head/Neck Prosthesis is marketed for cemented application. 55mm Resection 150mm 200mm 250mm Length Length Length P erformance P roven B i-Metric Revision Proximal Bi-Planar Stem Taper Provides enhanced proximal stress off-loading and initial implant stability. Titanium Alloy Plasma Spray Porous Coating The coating's closed pore design acts as a potential barrier to the migration of particulate debris and provides exceptional rotational stability and proven long-term fixation. Forged Titanium Ensures biocompatibility and fatigue strength; titanium displays a lower modulus of elasticity for enhanced load transfer. Collar Provides additional support and stress transfer in the calcar region and aids in rotational stability. Available Lengths The implant is offered in 200mm, Revision stems have a distal anterior bow 250mm, and 300mm options to address to anatomically fit the femur. expanded indications. Revision Stems are marketed for use with bone cement in the United States.

7 200mm 250mm 300mm Length Length Length P erformance P roven B i-Metric Primary Surgical Cut-line Trial head center, on femoral head center, in-line with the tip of the greater along trial head/broach trochanter Technique junction Rasp in-line 1. with femoral Step Femoral Head shaft Fig. 1. Resection Once the hip is dislocated, the femoral neck cut can be made either by using the femoral broach as a template (Fig. 1). or by using the femoral resection template (Fig. 2). Fig. 2. 2. Step Reaming the Distal Femur A starter drill bit (Fig. 3) or a hollow chisel (Fig. 4) can be used to open the femoral canal. Once the canal has been located, begin reaming with the smallest tapered reamer. Enlarge the canal in a sequential fashion until cortical chatter . is encountered (Fig. 5). Fig. 3 Fig. 4. Biomet , as the manufacturer of this device, does not practice medicine and does not recommend any particular surgical technique for use on a specific patient.

8 The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting the prosthesis in each individual patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. Fig. 5. Fig. 6. Broaching the Proximal Femur Begin broaching with the broach that is 2. or 3mm smaller than the last size reamer. It is important that the broach is oriented so that the medial/lateral axis of the broach is parallel with the anatomic medial/lateral axis of the femoral neck (Fig. 6). A sequentially larger broach is used until ideal or templated size is reached (Fig. 7). With the proper size 3. Step broach in place, the calcar can be planed flush by using the calcar trimmer *. (Fig. 8). Fig. 7. Fig. 8. Trial Reduction With the final broach still in place, provisional head/necks are selected to determine the appropriate neck length and to restore the lateral offset (Fig.)

9 9). A trial reduction is carried out to ensure that proper leg length and joint stability have been achieved (Fig. 10). 4. Step Fig. 9. * Pat. No. 4,306,550. Fig. 10. 5. Step a Inserting a Porous Component The stem corresponding to the size of the final broach is threaded onto the stem inserter/extractor and impacted into a fully seated position (Fig. 11). If desired, another trial reduction can be accomplished after implantation of the stem and prior to impacting the modular head onto the stem. Provisional heads in seven neck lengths allow trial reductions to be performed, using the actual femoral component, to again ensure proper leg length and stability. Fig. 11. After fully seating the femoral component, the appropriate modular head is impacted onto the femoral neck. The hip is now ready to be reduced. 5. Step b Inserting an Interlok Component The reaming and broaching are accom- plished in the same fashion as a porous component.

10 The implant should be under- sized by a minimum of 2mm to allow for adequate cement thickness. Example: Ream and broach to 11mm. Implant a size 9mm interlok stem. A distal cement restrictor is placed in the canal to allow a 2cm cement column below the tip of the stem (Fig. 12). Cement is injected into the canal in a retrograde fashion and pressurized. Slide appropriate sized distal centralizer onto stem. Example: A 9mm size stem accepts a 9mm centralizer sleeve. The stem is inserted to a fully seated position and extraneous cement is removed. Once cement Fig. 12. hardening has been achieved, a trial reduc- tion can be completed and the correct modular head chosen for reconstitution of leg length, lateral offset and stability. Inserting a Revision Component The revision components are an extended version of the primary stems utilizing the same design criteria. The revision compo- nent uses the same rasp as the primary stem devices.


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