Catalog Number 6260-9-236 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 09/01/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient arrived in er with discomfort in hip.Component failure discovered upon xray.The head disassociated from the stem.
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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.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.H3 other text : device not returned to the manufacturer.
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Manufacturer Narrative
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Reported event: an event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via clinician review of provided medical records and evaluation of the provided photographs of the devices.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show the trunnion of the stem is severely worn.Damage is consistent with loss of taper lock.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this product inquiry concerns a male patient who underwent a right total hip arthroplasty with a cobalt chrome femoral head with an accolade stem.The patient developed had neck disassociation with trunnionosis.I can confirm that the patient underwent both primary and revision surgeries since i was able to review the x-rays.I can also confirm that trunnionosis and trunnion deformity was present since i was able to see intraoperative photos displaying those findings.The root cause of this event cannot be determined with certainty.The causes of trunnionosis and head neck disassociation are multifactorial including surgical technique factors, especially in the preparation, or lack thereof, of the femoral head and trunnion prior to final insertion.Other factors include patient activity level and bmi as well as implant factors." 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 was revised due to disassociation of the head from the stem.The subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall pfa 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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It was reported that the patient arrived in er with discomfort in hip.Component failure discovered upon xray.The head disassociated from the stem.
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Search Alerts/Recalls
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