Catalog Number 999890143 |
Device Problem
Noise, Audible (3273)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994)
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Event Date 01/11/2016 |
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.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.
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Event Description
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Patient underwent a revision to address alval/soft tissue reaction, pain and noise.
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Manufacturer Narrative
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Left asr xl reason(s) for revision: alval / soft tissue reaction / pain/ noise bi-lateral patient.For right side see com 070504 received stem details on (b)(6) 2016.See product sticker email.Update alert date (b)(6) 2016 received email confirming future revision date.See email dated (b)(6) 2015 update nov 17, 2017: email notification received.Product and lot numbers differ from the information previously reported in the scf.These will remain unchanged.This complaint was updated on nov 22, 2017.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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