Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Naturally Worn (2988)
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Patient Problems
Calcium Deposits/Calcification (1758); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 08/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (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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Medical record received.After review of medical record, patient was revised to address synovitis with osteolysis.Revision notes stated that metal staining was noted.The source of metal staining appeared to be small amount of impingement in the posterosuperior neck of femoral component would impinge only with maximum external rotation and slight abduction.There was no impingement with regular extension, external rotation.Small divot on the femoral neck of the stem was noted and did not appear to be nearly big enough to warrant removing the well-fixed femoral component.If the liner had been poly instead of metal, certainly no metallic notching would have occurred.The posterior capsule was intact, except for a small hole about 1 cm in diameter.Extensive bone loss was noted.Manhole cover and liner were removed.After thorough debris irrigation, a manhole cover was placed and a new polyethylene liner was impacted.Heterotopic bone was debrided.Doi: (b)(6) 2006; dor: (b)(6) 2019; (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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