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 09/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10 - concomitant devices - persona cemented stemmed tibial component left size d catalog #: 42532006701 lot #: 66058128.G2 - report source - foreign: event occurred in saudi arabia.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.
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Event Description
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It was reported during knee arthroplasty that while the surgeon was inserting the articular surface, the locking mechanism was not functioning correctly.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.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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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