Catalog Number UNK-KNEE |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Date 11/04/2014 |
Event Type
Injury
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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 and 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.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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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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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Event Description
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Patient was revised to address tibial subsidence and loosening at the cement/implant interface.Competitor cement was used.
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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.Udi: (b)(4).
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Search Alerts/Recalls
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