Model Number 6260-9-036 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Discomfort (2330); Metal Related Pathology (4530)
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Event Date 10/06/2020 |
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.Device not returned.
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Event Description
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It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic (b)(6) femoral head on her right hip on or about (b)(6) 2013 and was revised on (b)(6) 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.
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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 the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2013 and was revised on (b)(6) 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.
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Manufacturer Narrative
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Reported event: an event regarding abnormal ion level involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: not 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 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.Conclusion: the event could not be confirmed as insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If 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 through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6), 2013 and was revised on (b)(6), 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.
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Search Alerts/Recalls
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