STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ACCOLADE TMZF STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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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 05/24/2020 |
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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.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 cocr v40 femoral head on her left hip on or about (b)(6) 2014 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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