Model Number 6260-9-336 |
Device Problems
Degraded (1153); Material Erosion (1214)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.
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Event Description
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As reported: "right hip revision due to gross trunnion failure." rep provided prior usage and an explant picture showing trunnion wear.Rep confirmed that while the femoral head was easily removed, it wasn't dissociated.Rep also confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event: an event regarding wear involving a metal head was reported.The event was confirmed via evaluation of the provided photograph of the stem.Method & results: -product evaluation and results: the reported device was not returned however a photograph of the stem was provided for review.Visual inspection of the provided photograph indicated that the stem is severely worn consistent with loss of taper lock.-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's hip was revised due to trunnion wear leading to loss of taper lock with the head.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.
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Event Description
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As reported: "right hip revision due to gross trunnion failure." rep provided prior usage and an explant picture showing trunnion wear.Rep confirmed that while the femoral head was easily removed, it wasn't dissociated.Rep also confirmed that no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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