Catalog Number UNK HIP INSTRUMENTS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Not Applicable (3189)
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Event Date 02/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Patient underwent an endoprosthesis procedure with a corail cemented stem due to a fractured hip.During the procedure, while the surgeon was broaching using the corail broach, the femur broke.It was a major fracture and surgeon had put a cable to fix the fracture and used a long revision stem.A total hip procedure was done instead of just an endoprosthesis procedure.The procedure was successfully completed with a surgical delay of one hour.The patient status is unknown.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > the device associated with this report was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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