STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ5 RIGHT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5512-F-502 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 05/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
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Event Description
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It was reported that the patient's right knee was revised.As reported by rep: "pt.Presented with thigh pain, imaging was indicative of a loose femoral implant following a knee-revision "back in (b)(6) of 2017".Surgeon ruled out infection and determined the femoral construct was aseptically loose.He performed a revision of the femoral implants, leaving the tibial baseplate and stem in-situ.No further information available." spoke to rep.No wear or damage was noted intra-operatively.
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Search Alerts/Recalls
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