Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Phlebitis (2004); Discomfort (2330); Test Result (2695); No Code Available (3191)
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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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Asr litigation record received.Patient alleges elevated metal ions, metallosis, pain, fatigue, and tenderness.Patient had elevated metal ion and underwent a revision surgery.Patient had phlebitis at the inferior right limb.Doi: (b)(6) 2006; dor: none reported (right hip).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary - the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa 00780 superseded by mdd capa-001226.
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Search Alerts/Recalls
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