Catalog Number UNK-ASR |
Device Problem
Metal Shedding Debris (1804)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Discomfort (2330); No Code Available (3191)
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Event Date 01/13/2014 |
Event Type
Injury
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Event Description
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Patient contacted depuy as a result of the asr recall to initiate a claim.Medical records were obtained.Medical records indicate patient was revised due to pain, elevated metal ion levels, discomfort and metallosis.Upon revision, synovitis, metal stained fluid, dark stained tissue, granulomatous tissue and a mostly fibrous ingrown cup (osseointegration of 2cm sq section) were noted.Legal claim was also received.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this investigation closed.
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Event Description
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Update rec'd 08/28/2014- litigation papers received.The doi was provided.There is no new additional information that would affect the investigation.The complaint was updated on: 09/11/2014.
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Search Alerts/Recalls
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