Catalog Number 157001090 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)
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Event Date 11/18/2014 |
Event Type
Injury
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Event Description
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Litigation alleges patient suffers from pain, foot drop, nausea, elevated cobalt chromium levels, and metallosis.
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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.(b)(4).
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.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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