Catalog Number 117904000 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 02/18/2015 |
Event Type
Injury
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Event Description
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Patient was revised to address tibial loosening, osteolysis and metallosis.Loosening occurred at the cement/implant interface.Cement manufacturer is unknown.
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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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The device associated with this report was not returned.A complaint database search finds no other reported incidents against the provided product and lot combination.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Mdepuy 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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