It was reported that the summit stem with pinnacle metal on metal implanted on 2005 presented with significant metallosis and osteolysis.It was also indicated that there was loosening of the stem at bone to implant interface.The proximal stem had 1 cm bone loss medial and from greater trochanter.It was explanted easily.The acetabulum had a significant defect superior.Pinnacle 300 series was still well fixed and difficult to remove.Interoperative cultures showed moderate signs of infection, so the surgeon decided to removed all components and implant a prostalac spacer.Doi: (b)(6) 2005, dor: (b)(6) 2019, right hip.
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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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