Catalog Number 999890147 |
Device Problems
Insufficient Information (3190); Noise, Audible (3273)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Tinnitus (2103)
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Event Date 06/12/2014 |
Event Type
Injury
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Event Description
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Asr revision, hip(s) to be revised: unknown.Type of hip replacement product: unknown.Reason(s) for revision: alval / soft tissue reaction.
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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.
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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.Depuy still considers this case closed to capa.
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Event Description
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Asr revision.Hip(s) to be revised: unknown.Type of hip replacement product: unknown.Reason(s) for revision: alval / soft tissue reaction.Update - added hip side, type of replacement, products x4.Taken from (b)(6) dated 10th july 2014.Right asr xl.
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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.Depuy still considers this case closed to capa.
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Event Description
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Asr revision.Hip(s) to be revised: unknown.Type of hip replacement product: unknown.Reason(s) for revision: alval / soft tissue reaction.Update - added hip side, type of replacement, products x4.Taken from claimsuite dated 10th july 2014.Right.Asr xl.Surgeon confirmation form received 1st september.Revision date amended.Additional surgeon and hospital added.Additional reasons for revision added.Reason(s) for revision: alval / soft tissue reaction, pain and noise, tinnitus.
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Search Alerts/Recalls
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