It was reported, that: on 08 sep 2021, a journal article was retrieved by our clinical team that reported a study from (b)(6) which looked at the effect of age on the outcomes of cementless mobile-bearing unicompartmental knee replacements.This study analysed the effect of age at the surgery on the mid to long term clinical outcomes of 1000 cementless ukr.Patients were categorised into four age groups (< 55, 55 to < 65, 65 to < 75 and = 75 years).Implant survival was assessed using endpoints reoperation, revision and major revision requiring revision knee replacement components.Functional outcomes were assessed.Complaint thirteen: the study reports revision ukr due to tibial avascular necrosis.Patient outcome: revision.
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(b)(4).This is a combined initial/final report and is being submitted to relay information.Report source, foreign - event occurred in (b)(6).The client has indicated that the product will not be returned to zimmer biomet for an investigation.Complaint summary: the product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.A historical search could not be performed as the item and lot number have not been provided.This device(s) is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device(s) when it/they left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided.No corrective action is required at this time as the root cause of the reported event has not been determined.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
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