balance Microplasty hip prosthesis Surgical TEchnique

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1 balance Microplasty hip prosthesis Surgical TEchnique Knees Hips Extremities Cement and Accessories PMI TEchnology

2 LEFT balance microplasty hip prosthesis +12mm Neck (46mm) +9mm Neck (43mm) +6mm Neck (40mm) +3mm Neck (37mm) Standard Neck (34mm) -3mm Neck (31mm) -6mm Neck (28mm) Porous Coating Level 0mm 10mm 20mm RIGHT 30mm 40mm 50mm 60mm 70mm 80mm 90mm 100mm X-Ray Te mplate Set Cat. No Biomet Orthopedics, Inc., P O.. Box 587, 56 East Bell Drive, Warsaw, IN B L NCE MICROPLASTY HIP PROSTHESIS 14.0mm x 80mm Part No Right Stem Part No Left Stem 20% oversize to allow for X-ray magnification 2005 Biomet Orthopedics, Inc. All Rights Reserved Figure 1 Figure 2 Preoperative Planning Mark the center of the head and intramedullary axis on the A-P radiograph. Estimate the size of Balance broach to be used, and determine the final resection level. Patient Positioning and Surgical approach The goal of the surgical approach is to establish adequate visualization of the anatomy so that the entire surgical area is exposed. The patient should be placed in a full lateral position secured with positioning devices to ensure complete patient stability. The Balance Hip Prosthesis is marketed for non-cemented use in skeletally mature patients undergoing primary hip replacement surgery as a result of noninflammatory degenerative joint disease. This surgical technique is utilized by Henry A. Finn, M.D. Biomet as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient.

3 Figure 3 Figure 4 Resection of the Femoral Neck Make a 45 degree resection of the neck 5 10mm above the proposed final resection level (Figure 3). Opening the Femoral Canal Use a 7mm starter reamer to initially open the cavity. Upon entry and without moving the reamer, shift and ream posterolaterally (Figure 4). 1

4 balance microplasty hip prosthesis Figure 5 Figure 6 Obtain Neutral Access to Canal and Size Introduce the conical reamer into the femoral neck, and gradually tilt the reamer posterolaterally. Ream the medial aspect of the greater trochanter until the reamer is in neutral alignment. Ream the diaphyseal canal, advancing down the canal. Increase the reamer size until cortical bone is contacted (Figure 5). contouring the stem envelope Option 1: Reaming to Remove Metaphyseal Cancellous Bone If performing broach only technique, skip to Option 2. With the last reamer used, pull and partially ream proximally. Tilt the reamer medially to the calcar region to remove medial cancellous bone. Tilt the reamer along the anterior cortex to the anterolateral aspect to remove the remaining metaphyseal bone (Figure 6). The goal of this step is to remove all cancellous bone in the upper 80mm of the femur to accommodate the 80mm length of the implant. Use Broach as a Trial Prosthesis Select a broach size that corresponds to the last size of conical reamer used. Assemble the broach handle to the broach body and use the broach as a trial prosthesis. Fully seat the broach with light mallet blows. Provide rotational stability and axial stability by cortical contact in the upper 80mm of the femur (Figure 7). 2

5 Figure 7 Figure 8 Option 2: Broaching to Remove Metaphyseal Cancellous Bone After opening the canal, a Balance Microplasty broach is used to contour the proximal stem envelope. Attach the broach handle to the broach by pulling back on the trigger to engage the broach. Begin the broaching process with the smallest Balance Microplasty broach. Progressively increase the broach size to enlarge the envelope until the ideal or templated size is achieved. Use care with insertion and removal of each broach to avoid excessive rotation and preserve the version of the femoral envelope (Figure 7). Trial Reduction Detach the broach handle. Leave the broach body in situ to serve as the trial prosthesis. Fit the trial head/neck provisional on the broach body (Figure 8). Perform a trial reduction and determine the appropriate neck length. Reattach the broach handle and remove broach. 3

6 balance microplasty hip prosthesis Figure 9 Stem Insertion Attach the stem inserter to the selected Balance Microplasty prosthesis. With proper prosthesis selection and adequate preparation of the proximal femur, stem implantation should require no more than 5 8mm of impaction with light mallet blows to achieve proper stability. If necessary, consider reapplying conical reamer to remove additional bone. Remove the stem inserter and mount trial femoral head (Figure 9). Reduce to check stability and range of movement. Remove the trial head. Impact the prosthetic femoral head on the neck using a plastic driver. 4

7 balance Microplasty hip prosthesis Implants Balance Implants, Trials & Broaches Product Implant Part # Trial Part # Broach Number Description Size x80mm RT 7x80mm LT 8x80mm RT 8x80mm LT 9x80mm RT 9x80mm LT 10x80mm RT 10x80mm LT 11x80mm RT 11x80mm LT 12x80mm RT 12x80mm LT 13x80mm RT 13x80mm LT 14x80mm RT 14x80mm LT 15x80mm RT 15x80mm LT 16x80mm RT 16x80mm LT 17x80mm RT 17x80mm LT 18x80mm RT 18x80mm LT 19x80mm RT 19x80mm LT 20x80mm RT 20x80mm LT 5

8 balance microplasty hip prosthesis Instruments Product Part Number Description Size No Image Available X-ray Templates No Image Available Balance MP Prov Right Inst Cs No Image Available Balance MP Prov Left Inst Cs No Image Available Balance MP Tprd Reamer Inst Cs No Image Available Balance MP Broach (RT) Inst Cs No Image Available Balance MP Broach (LT) Inst Cs Balance Microplasty Magnetic Trunnion x80mm 7x80mm 8x80mm 9x80mm 10x80mm 11x80mm 12x80mm 13x80mm 14x80mm 15x80mm 16x80mm 17x80mm 18x80mm 19x80mm 20x80mm 21x80mm 6

9 Product Part Number Description Size No Image Available x80mm 7x80mm 8x80mm 9x80mm 10x80mm 11x80mm 12x80mm 13x80mm 14x80mm 15x80mm 16x80mm 17x80mm 18x80mm 19x80mm 20x80mm 21x80mm 7

10 Biomet Orthopedics, Inc P.O. Box 587 date: 02/05 56 East Bell Drive Warsaw, Indiana USA Microplasty Hip Stem Attention Operating Surgeon DESCRIPTION The Microplasty Hip Stem is a porous coated femoral stem designed for use with any compatible Biomet modular heads and/or acetabular components to provide a total hip replacement system. MATERIALS Femoral Stems Titanium Alloy Porous Coating Titanium Alloy INDICATIONS 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2) Rheumatoid arthritis. 3) Correction of functional deformity. 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5) Revision of previously failed femoral head resurfacing component. For uncemented use only. Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity level, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, revision of total hip arthroplasty, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. WARNINGS Improper selection, placement, positioning, alignment and/or fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture, and/or excessive wear. Do not modify implants. The surgeon is to be thoroughly familiar with the implants and instruments prior to performing surgery. PRECAUTIONS Specialized instruments are designed for Biomet joint replacement systems to aid in the accurate implantation of the prosthetic components. The use of instruments or implant components from other systems can result in inaccurate fit, sizing, excessive wear, and device failure. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments that have experienced extensive use or excessive force are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been placed in a different patient, even if momentarily. POSSIBLE ADVERSE EFFECTS 1) Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant. 2) Early or late postoperative, infection, and allergic reaction. 3) Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device. 4) Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity. 5) Periarticular calcification or ossification with or without impediment of joint mobility. 6) Inadequate range of motion due to improper selection or positioning of components. 7) Undesirable shortening of limb. 8) Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions. 9) Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, and/or excessive weight. 10) Fretting and crevice corrosion can occur at interfaces between components. 11) Wear and/or deformation of articulating surfaces. 12) Trochanteric avulsion or non-union as a result of excess muscular tension, early weight bearing, or inadequate reattachment. 13) Problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies. 14) Postoperative bone fracture and pain. STERILITY Prosthetic components are sterilized by exposure to a minimum dose of 25 kgy of gamma radiation. Do not resterilize. Do not use any component from an opened or damaged package. Do not use implants after expiration date. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN USA, Fax Use Biomet femoral and modular head component with appropriate matching Type I Taper. 2. Firmly seat modular head components to prevent dissociation. Thoroughly clean and dry taper prior to attachment of the modular head component to avoid crevice corrosion and improper seating. 3. Acetabular screws are to be fully seated to assure stable fixation and to avoid interference with the acetabular liner component. 4. Prior to seating the liner into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component, as debris may inhibit the locking mechanism from engaging and securing the liner into the shell component. 5. Perforation entirely through the pelvic bone with dome fixation screws or rim screws is to be completely avoided. Caution is to be used when determining and selecting the length of screws to be used, as perforation through the pelvic bone with screws that are too long can cause damage to body structures (blood vessels, etc.) located on the interior side of the pelvis. 6. Tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure. Each component must properly press fit into the host bone which necessitates precise operative technique and the use of specified instruments. Bone stock of adequate quality must be present and appraised at the time of surgery. Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. While these devices are generally successful in attaining these goals, they cannot be expected to withstand the activity levels and loads of normal, healthy bone, and joint tissue. Accepted practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitation of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. Excessive activity, trauma, and/or weight gain have been implicated with premature failure of the implant by loosening, fracture, and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone making successful revision surgery more difficult. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including followup visits. The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein. 8

11

12 All trademarks belong to Biomet Manufacturing Corp. This material is intended for the sole use and benefit of the Biomet sales force and physicians. 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 herein and Biomet s website. P.O. Box 587, Warsaw, IN ext Biomet Orthopedics, Inc. Form No. BOI REV013108

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