Catalog Number 999890146 |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 09/23/2013 |
Event Type
Injury
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Event Description
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Asr revision ; asr xl; right; reason(s) for revision: the metallosis cause a status of anxiety, increasing metallosis in blood.This com is to be closed to capa due to the reasons for revision falling within the capa remit and off label use of a competitor stem.
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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.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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.(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.(b)(4).
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Manufacturer Narrative
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Depuy still considers this case closed to capa.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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Patient underwent a revision to address metallosis and elevated metal ions.
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Search Alerts/Recalls
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