Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Injury (2348)
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Event Date 10/02/2014 |
Event Type
Injury
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Manufacturer Narrative
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(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 proxima claim letter received.Claim letter alleges damages resulting from the high metal ion levels released by the hip implant.Doi: (b)(6) 2009; dor: (b)(6) 2014; unknown 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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.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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