Left side includes following devices: no186z - as univation xf femur cemented f2 lm, no163z - as univation xf tibia cemented t2 lm, nl471 - univation f meniscal comp.T2 rm/lm 7mm.Right side includes following devices: no181z - as univation xf femur cemented f2 rm, no157z - as univation xf tibia cemented t2 rm, nl471 - univation f meniscal comp.T2 rm/lm 7mm.Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are 2 similar complaints against the same lot number 52416316.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.Further investigations were initiated under a product safety case (psc).
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Associated medwatch-reports: 9610612-2020-00670 (400487303 no181z), 9610612-2020-00671 (400487304 no157z), 9610612-2020-00672 (400487307 no186z), 9610612-2020-00673 (400487308 no163z).Involved components: univation f meniscal comp.T2 rm/lm 7mm - 52410754.Univation f meniscal comp.T2 rm/lm 7mm - 52323238.
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