Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
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Event Date 04/08/2013 |
Event Type
Injury
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Manufacturer Narrative
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(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 claim letter and medical records received.Claim letter alleges metallosis and elevated chromium level.After review of medical records, the patient was revised to address pain.X-ray showed evidence of wear.There was significant metallosis secondary to the ball rubbing on the cup after the polyethylene had worn through.The polyethylene was dislodged from the cup.There was a small amount of burnishing on the inside of the cup.The cup was removed as well.Doi: (b)(6) 2011; dor: (b)(6) 2013; (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 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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Search Alerts/Recalls
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