Catalog Number 101214060 |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616); Insufficient Information (3190)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
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Event Date 11/12/2014 |
Event Type
Injury
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Event Description
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Patient was revised to address a femur fracture.
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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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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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No device associated with this report was received for examination.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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