Catalog Number UNK_SHC |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Injury (2348); Reaction (2414)
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Event Date 06/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, 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 or about (b)(6) 2013 and was revised on (b)(6) 2018.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.
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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 or about (b)(6) 2013 and was revised on (b)(6) 2018.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in his blood.
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Manufacturer Narrative
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Corrected manufacturing site for devices: an event regarding abnormal ion levels involving an unknown accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the item was not returned.Clinician review: not performed because no medical records or x-rays were made available for evaluation.Product history review: a review of the product history records could not be performed as the device was not properly identified.Complaint history review: a complaint history review could not be performed as the device was not properly identified.Conclusions: it was reported that the patient had excessive levels of chromium and cobalt in his blood.It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Search Alerts/Recalls
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