Pinnacle litigation received.Litigation alleges injury, pain, metallosis poisoning, tremors, cognitive difficulties, general fatigue, pseudotumors, corrosion debris, suffering, emotional distress, loss of mobility, loss of range of motion, disfigurement, and mental anguish.Doi: (b)(6) 2005; dor: none reported; left hip.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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 will be filed as appropriate.
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