The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) and complaint history review was unable to be performed as the lot/item number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.(b)(6).Literature: svard, u.C.G & price, a.J.(2001) oxford medial unicompartmental knee arthroplasty.J bone joint surg [br] 2001;83-b:191-4.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.(b)(6).Product location unknown.
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Information was received based on review of a journal article titled, "oxford medial unicompartmental knee arthroplasty" a patient was identified in the article that underwent a revision 11.9 years after initial surgery due to osteonecrosis with medical intervention.The patient was excluded from the study group and therefore, no further information was provided and the patient outcome is unknown.
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