(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.Unable to perform previous field action search 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.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2022-00145 and 3002806535-2022-00147.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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It was reported, that: on 14 sep 2021, a journal article was retrieved by our clinical team that reported a study from turkey which looked at the effect of changes taking place on the tibial slope of cementless unicondylar knee arthroplasties and defined its relationship with functional scores.This study analysed the patients undergoing a cementless unicondylar knee arthroplasty between january 2011 and july 2019.Overall, 161 cases were included.Patients were analyzed using standard radiographs for changes in pts, coronal positioning of the implant, and overhanging.This study showed that, with time, minimal changes take place in the pts of cementless unicondylar knee arthroplasty.The change mostly takes place during the first 6 months.These changes do not affect functional scores.Complaint four: the study reports revision due to infection in three patients.Patient outcome: revision.
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