Model Number NO157Z |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation on going.Additional information will be submitted in a supplemental report.
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Event Description
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It was reported that there was an issue with product as univation xf femur.According to the complaint description it was reported that the implant.Right side loosening after 3months and 18 days.A revision surgery has not yet been performed.Both knee were implanted.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2020-00670 ((b)(4) no181z), 9610612-2020-00672 ((b)(4) no186z), 9610612-2020-00673 ((b)(4) 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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Manufacturer Narrative
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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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Event Description
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Associated medwatch-reports: 9610612-2020-00670 (b)(4), 9610612-2020-00671 (b)(4), 9610612-2020-00672 (b)(4), 9610612-2020-00673 (b)(4).Involved components univation f meniscal comp.T2 rm/lm 7mm - 52410754, univation f meniscal comp.T2 rm/lm 7mm - 52323238.
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Search Alerts/Recalls
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