Active Articulation. Surgical Technique. Dual Mobility Hip System. Knees Hips Extremities Cement and Accessories PMI Trauma Technology

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1 Active Articulation Dual Mobility Hip System Surgical Technique Knees Hips Extremities Cement and Accessories PMI Trauma Technology

2 Active Articulation Dual Mobility Hip System Contents Preoperative Planning, Incision and Surgical Exposure... 1 Reaming and Cup Trialing... 2 Cup Orientation... 3 Positioning Guide Lateral Position... 5 Positioning Guide Anterior Supine (ASI) Position... 5 Cup Insertion... 6 E1 Bearing Trialing... 7 Assembly of the E1 Bearing and 28 mm Head... 8 Impacting the E1 Bearing Final Reduction Modular Head Removal Instrument Addendum Ordering Information Implants Instruments Package Insert... 21

3 Porous Coating Porous Coating Head Center 38mm I.D. x 44mm O.D. Cup Part No. US Head Center 40mm I.D. x 46mm O.D. Cup Part No. US Porous Coating Porous Coating 0mm 10mm Head Center 42mm I.D. x 48mm O.D. Cup Part No. US Head Center 44mm I.D. x 50mm O.D. Cup Part No. US mm Porous Coating Porous Coating 30mm 40mm 50mm 60mm 70mm Head Center 46mm I.D. x 52mm O.D. Cup Part No. US Head Center 48mm I.D. x 54mm O.D. Cup Part No. US mm 90mm 100mm Note: Porous coating level matches reamer diameter. Recommended ream diameter is 1 2mm smaller than the cup size. 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. X-Ray Template Set Cat. No Biomet Orthopedics, Inc., P.O. Box 587, 56 East Bell Drive, Warsaw, IN M 2 a Magnum Large Metal Articulation Acetabular Cup 20% oversize to allow for X-ray magnification 2004, 2005, 2008 Biomet Orthopedics, Inc. All Rights Reserved Figure 1 Figure 2 The Active Articulation E1 and ArComXL Dual Mobility Hip Systems utilize M 2 a-magnum cups and instrumentation for a straightforward approach to acetabular preparation. This brochure refers to, and contains images for, the Active Articulation E1 Hip System only. However, the content herein applies to both acetabular systems. Preoperative Planning, Incision and Surgical Exposure Accurate preoperative planning and templating are essential for obtaining a successful outcome. Estimate the acetabular size using the M 2 a-magnum templates (Part No ) along with the appropriate femoral templates in the A/P view (Figure 1). The surgical approach, head resection and acetabular exposure are left to the surgeon s discretion. M 2 a-magnum instrumentation is compatible with all routine hip exposures (Figure 2). This brochure demonstrates the surgical technique utilized by Richard Sweet, M.D. and William Berghoff, M.D. for the M 2 a-magnum cup and Jeffrey McLaughlin, M.D. for the Active Articulation E1 and ArComXL Dual Mobility Hip Systems. Biomet, as the manufacturer of these devices, does not practice medicine and does not recommend these devices or technique. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. 1

4 Active Articulation Dual Mobility Hip System Figure 3 Figure 4 Reaming and Cup Trialing M 2 a-magnum Cup Prepare the acetabulum using acetabular reamers, while maintaining the appropriate amount of anteversion and abduction as desired (Figure 3). Once the desired ream has been achieved, select the implant 1 2 mm larger than the final ream (e.g., ream to 54 or 55 mm for 56 mm implant). However, if bone quality is insufficient, line-to-line reaming may be appropriate. Prepare the acetabulum using acetabular reamers, while maintaining the appropriate amount of anteversion and abduction as desired (Figure 3). The M 2 a-magnum Tri-Spike cup should be reamed in a line-to-line fashion, under reaming by 1 mm if bone quality is insufficient. Use cup trials throughout the reaming process to help determine accuracy, size and position of the final prosthesis (Figure 4). Note: Prior to final cup insertion, evaluate osteophytes for possible impingement. If necessary, remove circumferential osteophytes. This can be done by leaving the final reamer in place as a guide to the degree of resection necessary. 2

5 Figure 5a Figure 6a Figure 5 Figure 6 Cup Orientation M 2 a-magnum Cup Once the final cup prosthesis is determined, select the corresponding locking impactor plate. Prior to securing the plate to the inserter handle, it is imperative that the ball bearings on the sleeve are fully exposed (Figure 5a). Attach the plate by firmly pushing the tip of the inserter onto the impactor plate (Figure 5). A click is felt and heard when the impactor plate is fully engaged. In order to establish correct cup positioning, the positioning guide can be attached onto the inserter handle (see page 5). Once the final cup prosthesis is determined, select the corresponding locking impactor plate. Prior to securing this plate to the inserter handle, it is imperative that the ball bearings on the sleeve are fully exposed (Figure 6a). Attach the plate by firmly pushing the tip of the inserter onto the impactor plate (Figure 6). A click is felt and heard when the plate is fully engaged. 3

6 Active Articulation Dual Mobility Hip System Figure 7 Figure 8 Cup Orientation (Continued) In order to establish correct positioning of the M 2 a-magnum Tri-Spike cup, the positioning guide can be used with the inserter handle (see page 5). Place the cup straight down in the wound (Figure 7), lightly setting the top two spikes into the acetabulum. Move the inserter handle into proper version and inclination, allowing the bottom spike to drop into position. Orient the cup so two spikes are placed superior in the ilium and one spike is placed inferiorly near the pubic ramus (Figure 8). 4

7 Figure 9 Positioning Guide Lateral Position Note: The primary guide for acetabular cup position should be based on the patient s anatomy. These instruments rely heavily on patient position and are intended to be used only as a secondary check. Screw the guide rods into the desired locations for inclination (40 or 45 degrees) and anteversion (15, 20, or 25 degrees). For a right hip, place the version guide rod in one of the holes on the right side of positioner, as the handle is pointing toward the patient. For a left hip, place the version guide rod in one of the holes on the left side of positioner, as the handle is pointing toward the patient. When positioning the acetabular shell, the version guide rod should be parallel to the floor, aimed toward the patient s ipsilateral shoulder and the inclination guide rod should point straight to the ceiling. If the inclination guide rod does not point to the ceiling, rotate the guide connector on the inserter handle until it does. Positioning Guide Anterior Supine (ASI) Position Screw the rods into the desired locations for inclination (40 or 45 degrees) and anteversion (15, 20, or 25 degrees). For a right hip, place the version guide rod in one of the holes on the left side of the positioner, as the handle is pointing towards the patient. For the left hip, place the version guide rod in one of the holes on the right side of the positioner, as the handle is pointing toward the patient. When positioning the acetabular shell, the version guide rod should be parallel to the floor, aimed up the patient s spinal column, and the inclination guide rod should point straight to the ceiling. If the inclination guide rod does not point to the ceiling, rotate the guide connector on the inserter handle until it does. 5

8 Active Articulation Dual Mobility Hip System Figure 12 Figure 10 Figure 11 Cup Insertion M 2 a-magnum and Once appropriate cup positioning is achieved, remove the positioning guide. When implanting the M 2 a-magnum Tri-Spike cup, avoid catching the spikes on soft tissue, the femur or the acetabular rim. In addition, avoid placement of spikes into cystic areas and particularly thin areas of the acetabular floor and wall, if possible. Once desired position is achieved, tap the inserter handle to set the spikes into the acetabulum 2 3 mm. Ensure cup position is accurate, then fully seat the cup by impacting with a surgical mallet. In some patients with hard bone, a two-stage insertion and impaction process is recommended. Use the locking impactor plate to obtain proper orientation and start cup impaction. Once satisfied with the cup position, stop impaction prior to seating the upper edge of the cup into the rim of the acetabulum. Remove the locking impactor plate and handle by turning the strike plate knob counter-clockwise (Figure 11), then lift the plate off the face of the cup (Figure 12). 6

9 Figure 13 Figure 14 Use the appropriately sized dome-loading ball impactor for final seating of the component (Figure 13). Note: Do not use an impactor or a metal-tipped punch on the rim of a standard M 2 a-magnum cup. If changes need to be made to the anteversion or inclination angles once the cup is impacted, use one of the optional face plates or a curved, plastic-tipped cup tamp. Tap on the plate to gradually change cup position. This will protect the inner diameter of the cup. E1 Bearing Trialing The size of the E1 Bearing used is determined by the size of the M 2 a-magnum cup that is implanted. The outer diameter (OD) of the bearing is always six mm less than the OD of the cup (i.e. a 60 mm cup utilizes a 54 mm E1 Bearing). The horizontal offset in the Active Articulation Hip System is controlled through the 28 mm femoral head. Trialing with the M 2 a-magnum head and neck trials helps determine the horizontal offset. Trial necks are available in six sizes (-6, -3, Std., +3, +6 mm). Screw the trial neck into the trial head then attach to the trunnion (Figure 14). Head and neck trials can be used in conjunction with both the cup trials and the final implants to determine joint stability and proper cup placement. With the cup in place, and upon completion of femoral reconstruction, a trial reduction should be performed to confirm restoration of leg length and hip stability. 7

10 Active Articulation Dual Mobility Hip System Figure 15 Figure 16 E1 Bearing Trialing (continued) Based on the trial head component and the estimated trial neck length, the corresponding 28 mm head must now be selected. Assembly of the E1 Bearing and 28 mm Head Completely unscrew (open) the Bearing Press. Slide the baseplate onto the forked end of the press (Figure 15). Tighten the baseplate to the press with the knob (Figure 16). 28 mm heads for the Active Articulation Hip System are available in one-piece cobalt chrome heads, one-piece BIOLOXdelta ceramic heads, or twopiece BIOLOXdelta Option ceramic head with taper sleeves. 8 Cobalt Chrome One- Piece Heads (Type 1) BIOLOXdelta Ceramic One-Piece Heads (Type 1) BIOLOXdelta Option Ceramic Head with Taper Sleeves (Type 1) BIOLOXdelta Option Ceramic Head with Taper Sleeves (12/14) -6, -3, Std, +3, +6-3, Std, +3-6, -3, Std, +3, +6-3, Std, +4, +7

11 Figure 17 Figure 18 Place the 28 mm head on the black lug of the baseplate (Figure 17). Position and hold the E1 Bearing above the 28 mm head. Rotate the press handle clockwise until the head is forced into the E1 Bearing (Figure 18) and a distinctive pop is heard. Note: If using a BIOLOXdelta Option ceramic head, insert the appropriate taper sleeve prior to placing the head on the black lug. Open the press by rotating the handle counterclockwise. Check that the 28 mm head rotates freely within the E1 Bearing. If it does not rotate freely, the 28 mm head is not properly engaged with the E1 Bearing. In this case, place the construct back on the bearing press and repeat the compression steps. 9

12 Active Articulation Dual Mobility Hip System Figure 19 Figure 20 Impacting the E1 Bearing The taper surfaces must be clean and dry before impacting. Place the assembled E1 Bearing on the neck of the final femoral implant then impact using the plastic head impactor (Figure 19). Using a non-compatible head impactor could damage the E1 Bearing. Final Reduction Reduce the Active Articulation hip construct into the M 2 a-magnum cup (Figure 20). Confirm joint stability, leg length and range of motion and begin customary repair of the hip capsule and wound. 10

13 Modular Head Removal Instrument Addendum T-Handle Inner Cylinder Figure 3 Incorrect Washer Position Outer Cylinder Figure 1 Figure 2 Figure 4 Correct Washer Position Modular Head Removal Instrument To Assemble Place the outer cylinder on a smooth, flat surface. Position the two white plastic washers against the heads of the hex screws so they match Figure 2 and do not look like Figure 3. Align the inner cylinder and outer cylinder and gently press the two parts together. Do NOT force the two parts together. If the parts do not slide together easily, try to tilt or twist the inner cylinder slightly until the two cylinders align. The cylinders should fit together securely. Loosening or tightening the hex screws is NOT recommended. After joining the cylinders, thread the t-handle into the inner cylinder by turning the handle clockwise. Figure 4 shows the instrument fully assembled. 11

14 Modular Head Removal Instrument Addendum Figure 5 Figure 6 Modular Head Removal Instrument (Continued) To Use Access to the medial side of the stem is necessary in order to use this instrument. Dislocate the head from the cup to expose the femoral component in a manner that allows access to the neck taper junction. Put the bearing removal tool in the fully closed or down position, and align the slot on the removal tool with the flats on the stem (Figure 5). Slide the removal tool into place, making sure the trunnion is as far back into the slot of the removal tool as possible (Figure 6). Firmly holding the outer cylinder, rotate the t-handle clockwise to expand the two cylinders (Figure 7). The handle will become very difficult to turn. 12

15 Figure 7 Figure 8 DO NOT TURN THE T-HANDLE WITHOUT FIRMLY HOLDING ONTO THE OUTER CYLINDER. YOU COULD RISK BREAKING THE FEMUR. If the handle becomes too hard to turn, try lightly impacting the head with a mallet. Alternatively, lightly impact the t-handle to rotate it further. DO NOT CAUSE ANY DAMAGE TO THE INSTRUMENT THAT WOULD PREVENT IT FROM BEING REMOVED. To Disassemble Hold the outer cylinder firmly in one hand and the t-handle in the other hand. Pull axially until the inner and outer cylinders separate (Figure 8). Remove the t-handle by twisting it counter-clockwise. Bearing release can be confirmed visually. If the head does not come loose, hold the outer cylinder firmly and rotate the t-handle counter-clockwise to release the pressure. ALWAYS LOOK FOR DAMAGE ON THE STEM THAT MAY HAVE BEEN CAUSED BY REMOVING OR ATTEMPTING TO REMOVE A HEAD. 13

16 Active Articulation Dual Mobility Hip System Implants 28 mm Ceramic Bioloxdelta Option Head Product Part Number Description Size Ceramic Bioloxdelta Option Head 28 mm Taper Sleeves for Ceramic Bioloxdelta Option Head Product Part Number Description Offset Type 1 Taper Sleeve Type 1 Taper Sleeve Type 1 Taper Sleeve Type 1 Taper Sleeve Type 1 Taper Sleeve -6-3 Standard /14 Taper Sleeve 12/14 Taper Sleeve 12/14 Taper Sleeve 12/14 Taper Sleeve -3 Standard mm Cobalt Chrome Modular Heads Product Part Number Description Offset CoCr Modular Head - No Skirt CoCr Modular Head - No Skirt CoCr Modular Head - No Skirt CoCr Modular Head - No Skirt CoCr Modular Head - No Skirt -6-3 Standard Active Articulation E1 Hip Bearings Product Part Number Description Size EP EP EP EP EP EP EP EP EP EP EP EP Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings Active Articulation E1 Hip Bearings 38 mm 40 mm 42 mm 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 14

17 Active Articulation ArComXL Hip Bearings Product Part Number XL XL XL XL XL XL XL XL XL XL XL XL Description Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Active Articulation ArComXL Hip Bearings Size 38 mm 40 mm 42 mm 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm M 2 a-magnum Cups Product Part Number Description Size US US US US US US US US US US US US M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup M 2 a-magnum Press Fit Cup 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm s Product Part Number Description Size US US US US US US US US US US US US mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 15

18 Active Articulation Dual Mobility Hip System M 2 a-magnum General Instrument Case A B Product Label Part Number Description Size A B M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Trial Cup M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate M 2 a-magnum Locking Impactor Plate 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 16

19 M 2 a-magnum Acetabular Instrument Case A B Product Label Part Number Description Size A B M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Cup Ball Impactor M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head M 2 a-magnum Trial Head 38 mm 40 mm 42 mm 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 38 mm 40 mm 42 mm 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 17

20 Active Articulation Dual Mobility Hip System M 2 a-magnum Acetabular Instrument Case (Continued) C Product Label Part Number Description Offset C M 2 a-magnum Trial Neck Type 1 M 2 a-magnum Trial Neck Type 1 M 2 a-magnum Trial Neck Type 1 M 2 a-magnum Trial Neck Type 1 M 2 a-magnum Trial Neck Type 1 Note: M 2 a-magnum trial necks, used for trialing the 12/14 taper sleeves (-3, standard,+4,+7), are not included in the M 2 a-magnum Acetabular Instrument Case (595207). See Additional Instruments on the following pages for ordering information. -6 mm -3 mm Standard +3 mm +6 mm 18

21 Additional Instruments Product Part Number Description Bearing Press Bearing Press Replacement Screw Jack Modular Head Removal Instrument S Curved Inserter Handle S Inserter Handle Replacement Cable S Inserter Handle Multi-Tool S Inserter Handle Cleaning Plate X Exact Offset Punch 19

22 Active Articulation Dual Mobility Hip System Additional Instruments Product Part Number Description S Straight Inserter Handle S M 2 a-magnum Adaptor Tip Head Impactor Offset Cup Tamp Replacement Tip-Conical Replacement Tip-Flat Head Reducer Shoehorn Product Part Number Description Offset M 2 a-magnum Trial Neck 12/ M 2 a-magnum Trial Neck 12/14 Standard M 2 a-magnum Trial Neck 12/ M 2 a-magnum Trial Neck 12/

23 Biomet Orthopedics, Inc P.O. Box 587 Date: East Bell Drive Warsaw, Indiana USA 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, even momentarily, in a different patient. All trial, packaging, and instrument components must be removed prior to closing the surgical site, do not implant. Active Articulation E1 Hip Bearing ATTENTION OPERATING SURGEON DESCRIPTION The Active Articulation E1 (Antioxidant Infused Technology) Hip Bearing is designed to fit over a 28mm modular head. The modular head articulates with the Active Articulation E1 Hip Bearing, which in turn articulates with a Biomet metal shell (Biomet M 2 a-magnum, M 2 a-magnum Tri-Spike, or M 2 a-38 Flared or Non-Flared). The components are intended for use with either primary or revision hip arthroplasties where all devices associated with the wear couple are removed and replaced. MATERIALS Active Articulation E1 Hip Bearing E1, highly cross-linked Ultra High Molecular Weight Polyethylene (UHMWPE) and α-tocopherol 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 by other techniques. 5. Revision of previously failed total hip arthroplasty. 6. Dislocation risks. The Active Articulation E1 Hip Bearing is a single-use implant, intended for uncemented applications. CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is 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, and/or 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. 1. Prior to seating the Active Articulation E1 Hip Bearing into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component. 2. The use of skirted or offset 28mm modular heads is not recommended. The use of these heads will result in a reduced range of motion. 3. Patient smoking may result in delayed healing, non-healing and/or compromised stability in or around the placement site. 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. 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. Further, there has been a report regarding an association between articulating surfaces of: 1) CoCrMo alloy on CoCrMo alloy, 2) CoCrMo alloy on polyethylene, and 3) Titanium alloy on polyethylene in hip replacements and increased genotoxicity. This report, however, did not assess either the clinical relevance of the data or make any definite conclusions as to which metal ions or interactions between metal ions or particulate metals might be responsible for the observed data. The report further cautioned that an association does not necessarily mean a causal relationship, and that any potentially increased risk associated with metal ions needs to be balanced against the benefits resulting from hip replacement. 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, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, and/or excessive, unusual and/or awkward movement and/or 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, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity. 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. E1 Implants MRI Information The effects of the MR environment have not been determined for this device. This device has not been tested for heating or migration in the MR environment. STERILITY Prosthetic components are sterilized by exposure to a minimum dose of 25 kgy of gamma radiation. Single Use Only. 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 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. CE Mark on the package insert (IFU) is not valid unless there is a CE Mark on the product (description) label. 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, unusual and/or awkward movement and/or activity, trauma, excessive weight gain, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation 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 follow-up visits. 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. 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 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. 21

24 Symbol Legend Manufacturer Date of Manufacture Do Not Reuse Caution Sterilized using Ethylene Oxide Sterilized using Irradiation Sterile Sterilized using Aseptic Processing Techniques Sterilized using Steam or Dry Heat Use By WEEE Device Catalogue Number Batch Code Flammable 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. 22

25 Biomet Orthopedics, Inc P.O. Box 587 Date: East Bell Drive Warsaw, Indiana USA 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, even momentarily, in a different patient. Active Articulation ArComXL Hip Bearing ATTENTION OPERATING SURGEON DESCRIPTION The Active Articulation ArComXL Hip Bearing is designed to fit over a 28mm modular head. The modular head articulates with the Active Articulation ArComXL Hip Bearing, which in turn articulates with a Biomet metal shell (Biomet M 2 a- Magnum, M 2 a-magnum Tri-Spike, or M 2 a-38 Flared or Non-Flared). The components are intended for use with either primary or revision hip arthroplasties where all devices associated with the wear couple are removed and replaced. MATERIALS Active Articulation ArComXL Hip Bearing ArComXL, highly cross-linked Ultra High Molecular Weight Polyethylene (UHMWPE) 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 total hip arthroplasty. 6. Dislocation risks. The Active Articulation ArComXL Hip Bearing is a single-use implant, intended for uncemented applications. CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who is 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, and/or 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. 1. Prior to seating the Active Articulation ArComXL Hip Bearing into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component. 2. The use of skirted or offset 28mm modular heads is not recommended. The use of these heads will result in a reduced range of motion. 3. Patient smoking may result in delayed healing, non-healing and/or compromised stability in or around the placement site. 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, unusual and/or awkward movement and/or activity, trauma, excessive weight gain, and obesity have been implicated with premature failure of certain implants by loosening, fracture, dislocation, subluxation 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 follow-up visits. All trial, packaging, and instrument components must be removed prior to closing the surgical site, do not implant. 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. Further, there has been a report regarding an association between articulating surfaces of: 1) CoCrMo alloy on CoCrMo alloy, 2) CoCrMo alloy on polyethylene, and 3) Titanium alloy on polyethylene in hip replacements and increased genotoxicity. This report, however, did not assess either the clinical relevance of the data or make any definite conclusions as to which metal ions or interactions between metal ions or particulate metals might be responsible for the observed data. The report further cautioned that an association does not necessarily mean a causal relationship, and that any potentially increased risk associated with metal ions needs to be balanced against the benefits resulting from hip replacement. 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, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption, and/or excessive, unusual and/or awkward movement and/or 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, malalignment, malposition, excessive, unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity. 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. ArComXL Implants MRI Information The effects of the MR environment have not been determined for this device. This device has not been tested for heating or migration in the MR environment. STERILITY Prosthetic components are sterilized by exposure to Gas Plasma. Single Use Only. Do not resterilize. Do not use any component from an opened or damaged package. Do not use implants past 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 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. CE Mark on the package insert (IFU) is not valid unless there is a CE Mark on the product (description) label. 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. 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. 23

26 Symbol Legend Manufacturer Date of Manufacture Do Not Reuse Caution Sterilized using Ethylene Oxide Sterilized using Irradiation Sterile Sterilized using Aseptic Processing Techniques Sterilized using Steam or Dry Heat Use By WEEE Device Catalogue Number Batch Code Flammable 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. 24

27

28 BIOLOXdelta is a trademark of CeramTec AG. All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. 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 x Biomet Orthopedics biomet.com Form No. BOI REV043011

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