Catalog Number 999890143 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Host-Tissue Reaction (1297)
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Event Date 01/15/2014 |
Event Type
Injury
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Manufacturer Narrative
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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.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 revision to take place on (b)(6) 2014.Asr xl - left, reason(s) for revision: alval / soft tissue reaction.
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Manufacturer Narrative
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Asr revision to take place on (b)(6) 2014.Asr xl - left.Reason(s) for revision: alval / soft tissue reaction.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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