Catalog Number 124152025 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Osteolysis (2377)
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Event Date 10/24/2014 |
Event Type
Injury
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Event Description
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Patient was revised to address poly wear and osteolysis.
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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.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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Manufacturer Narrative
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Additional narrative: depuy still considers this investigation closed.
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Event Description
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Update received 2/4/15.Clinical report states patient was revised to address poly wear and osteolysis.
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Search Alerts/Recalls
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