STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MRH FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_LIM |
Device Problems
Fracture (1260); Loss of Osseointegration (2408)
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Patient Problem
Pain (1994)
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Event Date 08/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the patient's right hinged knee was revised after patient complaint of thigh pain.Surgeon originally suspected femoral loosening.However, intra-op it was observed that the lateral condyle of the femoral component broke off of the implant and was loose in the joint.
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Manufacturer Narrative
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Reported event: an event regarding crack/fracture and loosening involving a mrh femoral component was reported.The event was confirmed for crack/fracture.Method & results: product evaluation and results: the reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component with fractured condyle.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient had pain; intraop it was observed that the implant was fractured and loose.The reported device was not returned; however, photographs were provided for review.The photographs show a recently explanted femoral component with fractured condyle.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that the patient's right hinged knee was revised after patient complaint of thigh pain.Surgeon originally suspected femoral loosening.However, intra-op it was observed that the lateral condyle of the femoral component broke off of the implant and was loose in the joint.
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Search Alerts/Recalls
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