Pcf and medical records.After review of medical records patient was revised to addressed infected right total hip arthroplasty, metallosis and adverse local tissue reaction.Operative notes indicated severe purulent in intraarticular area as well as the region between the adductor tendons and fascia lata.A pocket of pus anterior to the acetabulum.There was extensive osteolysis involving both acetabulum and proximal femur.There is no erosion in adductor tendons as inserted to the greater trochanter.Trunnions with black material about the head and neck junction.A fatty large lytic lesion on the medial neck of femur was noted.Debridement of pseudotumor and soft tissues were performed as well as the necrotic bone.Doi: (b)(6) 2010, dor: (b)(6) 2018, right 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.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|