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Catalog Number UNK-HIP |
Device Problems
Corroded (1131); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 08/25/2015 |
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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Litigation received.Litigation alleges pain, stiffness, discomfort, weakness, and increase metal toxicity.Update (b)(6) 2016 medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, loose cup with migration, and trunoninosis.
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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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Manufacturer Narrative
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Litigation received.Litigation alleges pain, stiffness, discomfort, weakness, and increase metal toxicity.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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Search Alerts/Recalls
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