Model Number 1218-87-456 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 04/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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 records received.After review of medical records patient was revised to addressed left total hip arthroplasty with history of metal on metal articulation.Operative notes indicated pain, limited range of motion, elevated metal ions level, mild staining of the pseudocapsule, moderate synovitis and trunnionosis.Doi: (b)(6) 2008 dor: (b)(6) 2019 left hip.Please see (b)(4) for 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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