Model Number NO188Z |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Failure of Implant (1924)
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Event Date 09/18/2019 |
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 loosening after 1years and 3 month.A revision surgery was on (b)(6) 2019 necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: (b)(4).9610612-2020-00669 (b)(4).Involved components univation f meniscal (b)(4).
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Manufacturer Narrative
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Investigation results: visual investigation: the components were examined microscopically.Little bone cement residues were visible.The coated surface shows little visible signs of abrasion.The origin of this traces are unknown.Possibly the traces were created during the explantation and are not related to the implant loosening.The provided x-ray figures give no hints regarding the root cause of the implant loosening batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are 2 similar complaints against the same lot number: 52328889 (all registered as involved component).Conclusion an measures: on the basis of the current information, a clear conclusion cannot be drawn.The device history records have been checked and no abnormalities could be observed.There are no hints for a material/device problem.Further investigations unter psc 2020-45 are on-going to define a definite root cause for the failure.
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Event Description
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The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00668 (400487297 no188z); 9610612-2020-00669 (400487298 no165z).Involved components: univation f meniscal (b)(4).
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Event Description
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Associated medwatch-reports: 9610612-2020-00668 (400487297 no188z), 9610612-2020-00669 (400487298 no165z).Involved components: univation f meniscal (b)(4).
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Manufacturer Narrative
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Investigation results: after further examination, it is not yet possible to determine the cause of the implant loosening.A material defect can be ruled out.Loosening of an implant can have many causes.For example, the cementing technique or also patient-related.
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Search Alerts/Recalls
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