(b)(4).Additional products: vanguard femoral component pn 183122, vanguard tibial bearing pn ep-183620, cruciate tray pn 141232, cobalt hv bone cement 40g pn 402282.Customer has not indicated that the product will be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-04585, 0001825034-2019-04593, 0001825034-2019-04598.
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Patient reported experiencing swelling, limited range of motion, instability and loosening approximately two years post left knee arthroplasty.Patient is unsure if it is the joint that is loose or the devices.Surgeon is suggesting devices be replaced.No revision has been reported.
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The patient states the event is due to doctor error; however, this statement cannot be confirmed and a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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