Catalog Number 999890147 |
Device Problems
Nonstandard Device (1420); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994)
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Event Date 07/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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Patient underwent a revision to address alval/soft tissue reaction and pain.
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Manufacturer Narrative
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Asr revision; right; xl; reason(s) for revision: pain , alval/soft tissue reaction.Update sep 15, 2017: email notification from kennedys received.There is no new information.This complaint was updated on: oct 05, 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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate 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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