Catalog Number 3L92498 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Loss of Osseointegration (2408)
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Patient Problem
Pain (1994)
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Event Date 07/23/2014 |
Event Type
Injury
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Event Description
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Patient was revised to address pain, leg length discrepancy and femoral stem loosening.Rep has also reported that the stem was also undersized.
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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.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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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