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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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 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.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.Device history lot: null.Device history batch: null.Device history review: null.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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