Catalog Number 999804047 |
Device Problem
Nonstandard Device (1420)
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Patient Problems
Pain (1994); Toxicity (2333)
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Event Date 05/25/2015 |
Event Type
Injury
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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.(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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Event Description
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Asr revision, asr resurface - left.Reason(s) for revision: pain, pseudo tumor, alval, metallosis.
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Manufacturer Narrative
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Asr resurface - left.Reason(s) for revision: pain, pseudo tumor, alval, metallosis update aug 18, 2017: email notification from (b)(6) received.There is no new information.This complaint was updated on aug 23, 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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