Model Number 42-5121-008-16 |
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 03/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an initial left total knee arthroplasty, the articular surface would not immediately seat onto the tibial tray during implantation.The surgeon was able to seat the bearing with some impaction.There was no patient impact and no adverse events have been reported as a result of this malfunction.The procedure was completed without further complication.
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Manufacturer Narrative
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(b)(4).Medical product: natural tibia cemented 5 degree stemmed left size e: catalog#42532007101, lot#65217767.Multiple mdr reports have been filed for this event.Please see associated report: 3007963827-2023-00061.The product will not be returned to zimmer biomet for evaluation, as the product remains implanted.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.However, from the follow up correspondence, it was found that surgeon had difficult in seating the articular surface, so he impacted the articular surface to seat them.A definitive root cause cannot be determined.However, we found that the surgeon deviated from the surgical technique to seat the final as into the tibial plate.Persona personalized alignment total knee arthroplasty surgical technique provides proper seating technique to assemble the articular surface into tibial plate.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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Search Alerts/Recalls
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