Model Number NR880M |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with nr880m - enduro meniscal component f2 10mm.According to the complaint description, the device was revised 2 years post surgery due to uncoupled implants.A revision surgery was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00800 (400539873 + nb011k), 9610612-2021-00801 (400539874 + nb015k).Involved components (aufführen in d11 + c2): nr292k - femur extens.Stem 6° d15x77mm cemented - lot 51857694; nr376k - enduro femur spacer post/dist f2 4x4mm - lot 51865091; nr378k - enduro femur spacer post/dist f2 8x4mm - lot 51745974; nr400k - nut f/femur extens.Stem all sizes neutr.- lot 51860012; nr192k - tibia offset stem d15x52mm cemented - lot 51875421.
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with nr880m - enduro meniscal component f2 10mm.According to the complaint description, the device was revised 2 years post surgery due to uncoupled implants.A revision surgery was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00800 (400539873 + nb011k), 9610612-2021-00801 (400539874 + nb015k).Involved components (aufführen in d11 + c2): nr292k - femur extens.Stem 6° d15x77mm cemented - lot 51857694; nr376k - enduro femur spacer post/dist f2 4x4mm - lot 51865091; nr378k - enduro femur spacer post/dist f2 8x4mm - lot 51745974; nr400k - nut f/femur extens.Stem all sizes neutr.- lot 51860012; nr192k - tibia offset stem d15x52mm cemented - lot 51875421.
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Manufacturer Narrative
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Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to change from leading material to involved component.All information regarding this case will be updated in 9610612-2021-00801 under aag reference (b)(4) ((b)(6)).Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.The provided x-ray figure shows a loosened rotation axis locknut.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 no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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.
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Event Description
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Correction: revision surgery after 9 years post-operatively.Nr880m changed from leading material to involved component.According to the complaint description, the device was revised 9 years post surgery due to uncoupled implants.Associated medwatch-reports: 9610612-2021-00801 ((b)(6) - nb015k).Involved components: nb011k - enduro tibial comp.Offset cemented t1 - lot 51873089.Nr292k - femur extens.Stem 6° d15x77mm cemented - lot 51857694.Nr376k - enduro femur spacer post/dist f2 4x4mm - lot 51865091.Nr378k - enduro femur spacer post/dist f2 8x4mm - lot 51745974.Nr400k - nut f/femur extens.Stem all sizes neutr.- lot 51860012.Nr192k - tibia offset stem d15x52mm cemented - lot 51875421.Nr880m - enduro meniscal component f2 10mm - lot 51876966.
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Search Alerts/Recalls
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