Pcf and medical records received.After review of medical records, patient was revised to address adverse local tissue reaction with metallosis after right total hip arthroplasty with significant lysis and greater trochanteric fracture along with pseudotumor.Operative notes stated that radiographs showed osteolysis and lucency under acetabular shell as well as elevated esr and crp.An aspiration of the hip revealed white blood cell count greater than 6000 as well as a left shift.A ct scan showed possibility of pseudotumor and elevated cobalt and chromium levels.Incision was made laterally, dissected down to the iliotibial band to gluteus medius vastus lateralis and found obvious greater trochanteric fracture that was comminuted as well as loss of the calcar when the stem was examined.There was a tremendous amount of metal stained tissue.The bone also appeared stained with metal debris.When the head was removed , the trunnion was exposed with significant amount of metal oasis.Attention was in acetabular component, significant amount of anteversion was noted.There was a large area of pseudotumor and was excised.There was also a fluid on the hip.There was a significant erosion of the acetabulum with loss of mainly the anterior wall.No indication of infection.There was significant amount of posterior impingement noted and the trunnion of the femoral stem had been impinge posteriorly on the cup for many years.Doi: (b)(6) 2008; dor: (b)(6) 2018 right hip.
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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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.
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