Catalog Number 999804451 |
Device Problems
Nonstandard Device (1420); Metal Shedding Debris (1804)
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Patient Problems
Pain (1994); Toxicity (2333); Reaction (2414)
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Event Date 02/11/2016 |
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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Asr revision not taken place.Asr resurfacing - right.Reason(s) for revision: alval / soft tissue reaction/increasing metal ions, pain.
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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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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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