Model Number NO183Z |
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 09/03/2019 |
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, left side.According to the complaint description it was reported that the implant loosening after 2 years and 1 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 (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2020-00666 ((b)(4) no161z), involved components: collect.No.Qas knee implants univation -unknown (no information about the inlay).
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Manufacturer Narrative
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Associated medwatch-reports: 9610612-2020-00666 (b)(4), 9610612-2020-00667 (b)(4).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.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 device problem.There are many factors which can lead to an implant loosening situation.
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Manufacturer Narrative
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Associated medwatch-reports: 9610612-2020-00666 (400487356 no161z); 9610612-2020-00667 (400487357 no183z).Involved components: collect.No.Qas knee implants univation: unknown.No product at hand, therefore an investigation at the product is not possible.The provided x-ray figures give no hints regarding the root cause of the implant loosening.On the basis of the current information and without the complained devices, a clear conclusion cannot be drawn.A product safety case was initiated.Based on 8 d report no capa is necessary.
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Search Alerts/Recalls
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