Pinnacle metal on metal litigation received.Litigation alleges injury, pain, implant failure, metallosis, swelling, lack of mobility, emotional distress, excessive levels of chromium and cobalt ions, damage to surrounding tissue and bone caused by an inflammatory response, pseudotumors, bursitis, and bone erosion.Doi: (b)(6) 2005; dor: (b)(6) 2018; 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 code(s) 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 will be filed as appropriate.
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