Catalog Number UNK-KNEE |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 09/03/2014 |
Event Type
Injury
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Event Description
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Patient was revised after she fell and broke her proximal femur, causing the implant to loosen at the cement/implant interface.The manufacturer of the cement used at the time of original implantation is unknown.
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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.Follow up with the complainant has been conducted for the catalog number and lot number, and this information is not available.
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Manufacturer Narrative
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The device associated with this report was not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product lot code required was not provided.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.Although no conclusive results were found, provided information suggest patient trauma could be a contributing factor.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 the 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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