Catalog Number 999890245 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Test Result (2695); No Code Available (3191)
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Event Date 01/28/2020 |
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 failed left total hip arthroplasty.Revision notes stated that the fluid underneath was murky but not frank terrible metalosis.Femoral head and cup were removed.Patient has a slightly shorter preoperative leg length on the left.Prior to the revision patient has pain and elevated metal ion.Doi: (b)(6) 2008.Dor: (b)(6) 2020.(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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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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