Catalog Number 999804451 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Necrosis (1971); No Information (3190)
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Event Date 06/10/2014 |
Event Type
Injury
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Event Description
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Asr revision.Asr resurfacing - left.Reason for revision: unknown.This is the first part of a resurfacing to xl revision.Cup remained in situ.Cup and resurfacing head implanted on (b)(6) 2006.Resurfacing head revised on (b)(6) 2007.Xl products implanted.Cup and xl products revised on (b)(6) 2014.Please see com (b)(4) for revision of the cup.
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Manufacturer Narrative
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Additional narrative:
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.
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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 case closed to capa.
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Event Description
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Asr revision.Asr resurfacing - left.Reason for revision: unknown.This is the first part of a resurfacing to xl revision.Cup remained in situ.Cup and resurfacing head implanted on (b)(6) 2006.Resurfacing head revised on (b)(6) 2007.Xl products implanted.Cup and xl products revised on (b)(6) 2014.Please see (b)(4) for revision of the cup.Query response received 19th september 2014.Reason for revision added.Reason for revision: aseptic necrosis of the left femoral head and neck.
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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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Search Alerts/Recalls
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