Model Number 6260-9-444 |
Device Problems
Degraded (1153); Material Erosion (1214)
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Patient Problems
Foreign Body Reaction (1868); Metal Related Pathology (4530)
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Event Date 04/26/2022 |
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.
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Event Description
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It was reported through claimant's counsel that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.During the revision the surgeon noted "¿ there was a significant amount of black metallosis fluid encountered.An extensive debridement of all metal debris was performed and it was found that his trunnion was completely destroyed.".
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Event Description
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It was reported through claimant's counsel that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.During the revision the surgeon noted "¿ there was a significant amount of black metallosis fluid encountered.An extensive debridement of all metal debris was performed and it was found that his trunnion was completely destroyed.".
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Manufacturer Narrative
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Reported event: an event regarding wear (metallosis) involving an metal head was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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: 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 (b)(6) 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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Search Alerts/Recalls
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