After review of medical records patient was revised to address failed left total hip arthroplasty secondary to metallosis, left hip bearing and greater trochanteric femur fracture, pathologic.Revision notes reported that the patient has developed a squeaking sensation in his left hip.Serum cobalt and chromium were checked, both of which were up in the 40s and anterior synovium of the hip was clearly stained from the metallosis.Doi: (b)(6) 2008, dor: (b)(6) 2019, (left hip).
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for 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 will be filed as appropriate.
|