Catalog Number 155522000 |
Device Problem
Disassembly (1168)
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Patient Problem
Pain (1994)
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Event Date 08/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable.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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Event Description
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Patient was revised to address pain and disassociation.
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Manufacturer Narrative
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No device associated with this report was received for examination.Dhr reviews did not find any anomalies that would have contributed to the reported event.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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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