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 05/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) multiple mdr reports were filed for this event, please see associated reports: 3007963827-2023-00153 and 0001822565-2023-01560.D10 medical devices: tibia fixed cemented right size f catalog#: 42542007502 lot#: 65845201 unknown femoral catalog#: ni lot#: ni g2 foreign source: japan customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 knee procedure, the tibial insert would not seat on the tibial tray.A impactor was used to seat the tibial insert into the tray.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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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