Catalog Number 3L92503 |
Device Problems
Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 12/11/2014 |
Event Type
Injury
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Event Description
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Patient was revised to address a fractured femur and a loose and subsided femoral stem as a result of a fall.It was also noted that the patient had dislocated.
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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 devices associated with this report were not returned.A complaint database search finds no other reported incidents against the provided product and lot combinations.The initial reporting stated no additional investigational inputs were available.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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Search Alerts/Recalls
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