Model Number N/A |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Information (3190)
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Event Date 09/01/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr's were submitted for this event.Please see reports: 0001822565 - 2017 - 07351, 0001822565 - 2017 - 7352.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the articular surface implants were noted to be difficult to seat in the tibial tray.A piece of cement was removed from the tibial tray.The surgery was completed with a third device.No further information is available at this time.
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Manufacturer Narrative
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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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Event Description
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It was reported the articular surface implants were noted to be difficult to seat in the tibial tray.A piece of cement was removed from the tibial tray.The surgery was completed with a third articular surface.Operative records noted that the surgeon let down the tourniquet, gave pressure, and gave electrocautery for hemostasis during an unknown delay while the third articular surface was retrieved.No further information is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no trends were identified.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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