Catalog Number UNK-HIP |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 12/17/2015 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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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Litigation alleges patient was revised to address pain, elevated ions, and femoral loosening.Metal staining of the periarticular synovium was also noted.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.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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