INSERTION TECHNIQUE. *CAUTION: Investigational device. Limited by Federal Law (USA) to investigational use only.

Transcription

1 INSERTION TECHNIQUE *

2

3 The nature of hard-on-hard bearings requires precise placement of femoral and acetabular components. It is important to optimize component placement to avoid mechanical impingement. To ensure optimal component placement when using alternative bearings, trialing is critical. Dedicated trials for alternative bearings help ensure the correct representation of biomechanics. If the restoration of joint biomechanics is not established with the alternative bearing trials, a trial reduction using the Pinnacle polyethylene liner trials should be performed. The Pinnacle polyethylene liner that results in joint stability should then be used. NOTE: If any other bearing surface has been impacted into the shell, a Ceramax insert cannot be used. Ceramax inserts should only be used in new Pinnacle acetabular shells with an as manufactured taper.

4 * INSERTION TECHNIQUE STEP 1 Before placing the Ceramax insert into the Pinnacle shell, ensure all mating surfaces are clean and free of debris (FIGURE 1). Handle the Ceramax insert carefully to avoid damage that could compromise the mechanical integrity of the insert taper locking mechanism. 28 mm ID Alternative Bearing Trial FIGURE 1 STEP 2 Attach the suction cup inserter to the Ceramax insert inner diameter. Cautiously advance the insert to ensure circumferential alignment of the taper mechanism (FIGURE 2). Palpate the insert to confirm proper taper alignment and seating in the shell. The insert should sit flush relative to the face of the shell. Apply finger pressure to ensure initial locking of the taper mechanism. Do not attempt to fully engage the taper locking mechanism by striking the end of the suction cup inserter. FIGURE 2 STEP 3 It is important to cautiously release the suction cup insertion instrument from the Ceramax insert so the insert does not disengage from the shell. It is recommended that the Ceramax insert be secured with a thumb and forefinger placed superiorly and inferiorly, while the suction cup instrument is disengaged from the insert (FIGURE 3). FIGURE 3 STEP 4 Prior to final impaction, examine the insert to ensure it is seated evenly relative to the shell face. Use an impactor with a 28 mm impactor tip for final seating of the Ceramax insert. Final seating requires two to four moderate blows (FIGURE 4). FIGURE 4 In the event that the Ceramax insert is impacted and does not seat properly in the shell, it must be removed as shown in the removal technique. After removal of a Ceramax insert that has been impacted, only a polyethylene or metal insert may be used in the shell due to potential damage to the shell taper. An insert that has been placed as shown in steps 2 and 3 may be removed and reinserted prior to impaction.

5 * REMOVAL TECHNIQUE STEP 1a If it is necessary to remove a Ceramax insert from a Pinnacle shell, thread the extractor handle onto the appropriate size alternative bearing extractor (FIGURE 1a). FIGURE 1a Each shell size has a specific extractor, e.g., 48 mm shell uses a 48 mm extractor. STEP 2a Place the three tips of the AB extractor into any three scallops on the face of the Pinnacle shell (FIGURE 2a). FIGURE 2a STEP 3a Push the attached lever down with thumb pressure to engage the suction cup to the inner diameter of the Ceramax insert (FIGURE 3a). FIGURE 3a STEP 4a To remove the Ceramax insert from the shell, tap the extractor handle lightly one to two times with a mallet. The resulting vibration will release the taper lock between the Ceramax insert and the Pinnacle shell. Lift the insert out of the shell with the suction cup mechanism (FIGURE 4a). FIGURE 4a

6 Use only the following femoral heads with the Ceramax insert. The use of femoral heads other than the DePuy BIOLOX delta heads listed below is contraindicated for use with Ceramax inserts and may compromise performance. Articul/eze BIOLOX delta Ceramic Heads, 28 mm (12/14 Taper) Size (mm) S-ROM BIOLOX delta Ceramic Heads, 28 mm (11/13 Taper) Size (mm) Ceramax Inserts, 28 mm ID IDE OD (mm) * * * * * * * * * * 66 Alternative Bearing Trial Inserts, 28 mm ID OD (mm) Alternative Bearing Extraction Instruments Description Extractor Handle (Duraloc Polyethylene Liner Impaction Handle) AB Extraction Instrument Tray Alternative Bearing Extractors Size (mm) Alternative Bearing Insertion Instruments Description Alternative Bearing Suction Cup Inserter Replacement Suction Cup Tip mm Impactor Tip BIOLOX is a registered trademark of CeramTec A.G..5M Printed in USA DePuy Orthopaedics, Inc. All rights reserved.