This report is being submitted to relay additional information.The following sections have been updated: the following sections have been corrected: device was implanted on unknown day in 2006 item # 00642803201, alumina ceramic femoral head, lot # unk contact phone number complaint sample was evaluated and the reported event was confirmed.As returned, the liner is severely damaged from explanting.The rim feature is partially fractured.The backside surface exhibits deep gouging.Damage is too severe for dimensional analysis.The reported event was confirmed with the review of radiographs.From the x-ray review : curvilinear metallic focus seen inferior to the femoral neck on the ct.Finding is also seen in this same location on the plain films.Radiolucency noted along the proximal femoral stem.Contour irregularity of the superior acetabular cup.There is a right total hip arthroplasty in place superficially seated within the right femur.There is radiolucency along both sides of the proximal femoral stem.There is irregularity of the appearance of the entire acetabular cup with evidence of acetabular liner loosening and hardware disassembly.Curvilinear metallic focus inferior to the femoral neck is present with mild bony fragmentation , possibly heterotopic ossification.Streak artifact does limit evaluation.The acetabular liner may be fractured inferiorly.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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