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 08/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical devices - persona cemented stemmed tibial component left size c catalog #: 42532006401 lot #: 65212421.Report source - foreign: japan.The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.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 knee arthroplasty while the surgeon was inserting the articular surface, it would not click into the tibial tray.Another articular surface was used to complete the procedure.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product found the locking features to be flared out.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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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