Model Number N/A |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Information (3190)
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Event Date 06/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: partial femur cemented p/n: 42558000601, l/n: 63540146.Partial articular surface p/n: 42518200509, l/n: 63425032.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to it was discarded at the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the patient underwent a left knee revision 16 months post-implantation due to loosening.No additional patient consequences were reported.
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Manufacturer Narrative
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Udi # (b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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Reported event confirmed by review of the op notes.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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