Catalog Number UNK-ASR |
Device Problem
Corroded (1131)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 09/14/2015 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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Event Description
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Medical records received.Medical records reviewed for mdr reportability.Three pages of left hip revision surgical report were received with dor of (b)(6) 2015.Revision surgical report noted implant failure of a recalled acetabular component, brown tissue and trunnion corrosion.Unknown depuy asr cup, head, sleeve and stem are being reported.
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Manufacturer Narrative
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The asr platform was voluntarily recalled from the market in (b)(6) 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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Search Alerts/Recalls
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