STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5517F501 |
Device Problems
Unstable (1667); Malposition of Device (2616); Unintended Movement (3026)
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Patient Problem
Injury (2348)
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Event Date 05/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding revision due to instability involving a triathlon femoral component was reported.The event was confirmed based on the clinician review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary: arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.An adverse mix of procedure-related factors regarding component malposition and patient-related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.An adverse mix of procedure-related factors regarding component malposition and patient-related factor of morbid obesity have contributed to instability in the left knee arthroplasty with possibly additional tibial device loosening requiring revision surgery with exchange of all components.X-rays and return of the device are needed to further investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Device not available.
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Event Description
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It was reported through the communication of an attorney that allegedly the patient was revised due to "left knee, failed total knee arthroplasty." update to event description based on clinician review of the medical records provided: regarding cause of failure of the left knee requiring revision surgery in (b)(6) 2017, some 3-years post primary, there is limited information.Primary arthroplasty had no complications although at 3-years follow-up the knee was documented as chronic unstable with mid-flexion instability.The instability was confirmed during revision while additionally the surgeon observed that only some 20% of the tibial bone ingrowth surface showed signs of bone ingrowth.All components were removed and replaced with competitor devices including the previously unresurfaced patella.
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Search Alerts/Recalls
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