Catalog Number UNK-HIP |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Joint Swelling (2356)
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Event Date 11/03/2015 |
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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Patient was revised due to pain.Update (b)(6) 2016 medical records received.Medical records were reviewed for mdr reportability.Patient age, dob and doi to be updated.Revision surgical note reported adverse metal reaction, very large fluid collection and corrosion.Unknown stem added to complaint for corrosion.The complaint was updated on: (b)(6) 2016.
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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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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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.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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