There were no allegations reported in the pinnacle claim submission form.After review of medical records it was reported that the patient was revised to address failed left total hip arthroplasty and antiprotrusio cage and bone graft with massive acetabular bone loss.Revision note stated, the femur component was found to be intact without evidence of loosening.The head is the only confirmed depuy implanted to the patient 10 years ago.Doi: 10 years ago - dor: (b)(6) 2008, (left hip, first revision).Please see (b)(4) for the second revision.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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