Catalog Number 103543000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Information (3190)
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Event Date 12/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Event Description
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Patient was revised to address dislocation.
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Manufacturer Narrative
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Patient was revised to address dislocation.Examination of the reported device was not possible as it was not returned.A search of the complaints databases finds no other reports against the product and lot code combination since its 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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Manufacturer Narrative
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Depuy still 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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