Catalog Number UNK-HIP |
Device Problem
Insufficient Information (3190)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 01/20/2014 |
Event Type
Injury
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Event Description
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Patient was revised to address stem loosening and pain.Update rec'd 12/8/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from toxic cobalt-chromium metal ions, discomfort, and inflammation.An unknown head and liner are now being added to address metal on metal allegations.
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Manufacturer Narrative
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Additional narrative: 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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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.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.
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Search Alerts/Recalls
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