ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MEDIAL CONGRUENT ARTICULAR SURFACE RIGHT 10MM; PROSTHESIS, KNEE
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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 01/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant devices - persona cemented stemmed tibial component right size e catalog #: 42532007102 lot #: 65046964, persona cemented cruciate retaining narrow femoral component right size 8 catalog #: 42502006402 lot #: 65062629.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 the articular surface could not be seated in the tibial tray.Multiple attempts were made, however, another device was used to complete the procedure.The procedure was delayed ten (10) minutes, however, 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 product was evaluated through manufacturing review, however, the reported event could not be confirmed.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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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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The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h10.The complaint sample was returned and visual examination of the articular surface showed signs of use (nicked/gouged) and the dovetail feature was flared out, confirming the device would not have been able to seat.The root cause remains unchanged at this time.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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