(b)(4).Multiple mdr's were reported for this event.Please also see associated events: 3002806535 - 2018 - 00522; 3002806535 - 2018 - 00524.Concomitant medical products: 154601 oxford uni femoral md, lot j3336632; 159576 oxf anat brg rt md size 4 pma, lot 3395254.Report source: foreign.The event occurred in the (b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Device remains implanted.
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Clinical study (b)(4) - it was reported that patient had severe to extreme pain, feeling knee might suddenly give away "most of the time", extreme difficult performing daily activities, constant limping requiring cane as a walking aid six months post implant.Additionally, patient has pain syndrome and depression listed as confounding orthopedic problems affecting the knee.Attempts have been made and no further information has been made available at this time.
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