Product complaint # (b)(4).Initial reporter occupation: lawyer.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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Pinnacle claim and litigation records received.Patient alleges pain, loss of balance, dizziness, difficulty walking, elevated chromium and cobalt levels, metallosis, tissue dehiscence, tissue necrosis, hypertrophic scarring, antalgia, lumbar strain, chronic fatigue and emotional distress.Doi: (b)(6), 2011 dor: unk, right hip.
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