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 10/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign - (b)(6).The customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is unavailable by hospital policy.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 an initial knee arthroplasty, the surgeon had difficulty inserting the articular surface.He removed the poly to inspect the rear of tray.A small amount of cement was found.The poly was inspected and there was damage to the locking mechanism.The surgeon elected to open an mc poly instead.There was no consequences or impact to the patient.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.A visual inspection was performed of the provided photographs attached in the subform for item # 42522000510 lot # 64973071 and found the distal surface to exhibit damage (nicked gouged) and the dove tail / locking features to be compressed and flared out.The dhr was reviewed and no discrepancies relevant to the reported event were found.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in persona- the personalized knee surgical technique.The root cause is attributed to user error.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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