Zimmer biomet complaint number (b)(4).G4: additional pma/510(k) number ¿ k011028 | k013227.Zimvie received the reported implant for evaluation.Visual evaluation / functional test was performed, implant shows slight wear and mount cannot be disengaged.Malfunction.Dhr review was completed for the subject lot number 2021010261.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2021010261 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was torque or speed applied during placement/seating exceeds recommended value.Therefore, based on the available information, device malfunction did occur.The mount was not able to disengage from implant.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
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