Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Naturally Worn (2988)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Initial reporter occupation: lawyer.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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Event Description
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Pinnacle litigation record received.Plaintiff alleges that after the surgery, friction and wear between the metal head and metal liner has caused large amounts of toxic cobalt-chromium ions and particles to be released into the patient's blood, tissue and bone surrounding implant.The patient has been experiencing severe pain, discomfort and inflammation.Doi: (b)(6) 2008 - dor: none reported (left hip).
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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