Claim and medical records received.After review of claim and medical records, it was stated that the patient was revised to address pain and aseptic loosening of cup component.Stiffness, limping, clicking, popping, weakness and numbness were also noted.Operative notes reported slightly brown tented and translucent fluid, the tissue is stained dark gray consistent of metallosis, two superior cysts were curetted and there was no acetabular bony ingrowth noted.When removing the acetabular shell, three screws broke but only one was fully extracted and the two screws were recessed since they were embedded into the sclerotic bone.Mri reported trochanteric bursitis.X-ray reported aseptic loosening of acetabular component and has metal wear debris reaction.Doi: (b)(6) 2010; dor: (b)(6) 2018; left hip.
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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.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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