Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Local Reaction (2035); Joint Disorder (2373); Blood Loss (2597); Test Result (2695); No Code Available (3191)
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Event Date 03/11/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Complaint description: patient was revised to address pain.Update ad 24 dec 2019: (b)(4) has been reopened under (b)(4) due to the receipt of pinnacle claim submission form and medical record.After review of medical record, patient was revised to address failed right total hip arthroplasty revision with metal on metal total hip replacement with elevated metal ions.Revision notes stated that there was particulate debris.There was some synovial proliferation.Femoral head was removed and there was noted to be some corrosive changes of the trunnion.There was some bleeding below the acetabulum.Also took down some anterior impingement bone.Added stem due to elevated metal ions.Doi: (b)(6) 2008; dor: (b)(6) 2015 (right 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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