Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown 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 that during a total knee arthroplasty, the tibial insert would not seat into the tibial tray.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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