Catalog Number UNK_SHC |
Device Problems
Degraded (1153); Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
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Event Date 04/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding abnormal ion level involving an unknown accolade stem was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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It was reported that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2012 and was revised on (b)(6) 2018.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, 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 an accolade stem stem 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 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 excessive levels of chromium and cobalt in her blood.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision 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 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 allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on her right hip on or about (b)(6) 2012 and was revised on (b)(6) 2018.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, and excessive levels of chromium and cobalt in her blood.
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Search Alerts/Recalls
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