Catalog Number 3L92510 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/08/2014 |
Event Type
Injury
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Event Description
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During implantation, the medial calcar of the femur fractued when inserting the stem.
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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 and is presumed yet implanted.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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Search Alerts/Recalls
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