Pinnacle litigation received.Litigation alleges injury, pain, discomfort, loss of mobility, loss of range of motion, disfigurement, emotional distress, difficulty ambulating, mental anguish, metallosis which caused a large amount of toxic cobalt and chromium metal ions to be released into the hip capsule, tissues, blood stream, and organs.Doi: (b)(6) 2005; dor: (b)(6) 2017; right 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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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