Catalog Number 999890146 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Pain (1994); Injury (2348); Depression (2361); No Code Available (3191)
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Event Date 10/08/2012 |
Event Type
Injury
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Event Description
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Asr revision, asr xl - left, reason for revision: pain, metallosis and elevated metal ions.
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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.Ref.Wwcapa (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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In addition to what was previously reported, claim letter alleges injury, reactive depression and build up of synovial fluid.
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Manufacturer Narrative
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(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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