ZIMMER BIOMET, INC. VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 12MM X 79/83MM; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Degraded (1153)
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Patient Problems
Ossification (1428); Pain (1994); Joint Laxity (4526)
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Event Date 11/16/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a right knee arthroplasty revision to address pain and femoral screw migration approximately five (5) years post-operatively.During the revision, the tibial bearing was also identified to be damaged from contact with the loose screw.The tibial bearing and locking bar were replaced.The femoral construct remained well-fixed with no signs of loosening, so the surgeon did not feel it was necessary to replace the migrated screw.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).D10 - concomitant devices - vanguard ssk 360 femoral component right 65mm catalog #: 185264 lot #: 6256720, biomet 360 tibial tray 79mm catalog #: 185205 lot #: 182670, biomet 360 tibial large cruciate wing catalog #: 185651 lot #: 987170, biomet splined knee stem 15mm x 80mm catalog #: 148305 lot #: 115340, biomet 360 2.5mm offset adapter catalog #: 185210 lot #: 711920, biomet splined knee stem 15mm x 120mm catalog #: 148318 lot #: 384280, vanguard series a standard 3-peg patella 37mm catalog #: 184768 lot #: 035180.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2023-02968.
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Event Description
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It was reported that the patient underwent a right knee arthroplasty revision to address pain and femoral screw migration approximately five (5) years post-operatively.During the revision, the tibial bearing was also identified to be damaged from contact with the loose screw.The tibial bearing and locking bar were replaced.The femoral construct remained well-fixed with no signs of loosening, so the surgeon did not feel it was necessary to replace the migrated screw.No additional patient consequences were reported.Initial operative notes noted no intraoperative complications.Revision operative notes noted that the patient had increased laxity in varus and valgus as well as in flexion prior to the tibial bearing being removed.The loosened femoral screw was identified posterior lateral and was removed without difficulty.Heterotopic bone was also identified and removed from the patella.No intraoperative complications were identified.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, h2, h3, h6.The reported event was confirmed by review of the provided medical records and returned product.The femoral component remains implanted and was not returned, however the femoral locking screw was returned.Visual evaluations found the threads are stripped.Visual examination of the bearing found signs of use, nicked and gouged.The locking bar was returned, however it was damaged during removal and no further evaluation was performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records and radiographs were provided and reviewed by a healthcare professional.Review of the records identified that patient was negative for infection.Proximal and lateral heterotopic bone was excised; laxity identified, and no intraoperative complications were reported.Radiographs found no evidence of fracture or implant loosening.A radio-opaque object is noted posterior to the femoral implant consistent with the displaced screw.A definitive root cause cannot be determined for the disassociated screw and wear to the bearing.Failure to replace the femoral stem screw during the procedure can be attributed to a failure to follow instructions.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information to report.
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