Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Asr xl litigation records received.Litigation alleges injury, metallosis and implant failure.After review of medical records, the patient was revised due to metal hypersensitivity and osteolysis.Operative notes reported that there was evidence of a pseudocapsule or cystic mass extending into the peritrochanteric space into the joint.There was evidence of metallosis at the trunnion, after inspection there were no visible damage to the femoral trunnion.Assessment of the acetabular bone demonstrated a large cystic lesion.There was also a secondary containing osteolytic lesion in the posterior column extending into the ischium.Doi: (b)(6) 2009.Dor: (b)(6) 2017; (left hip).
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