(b)(4).Implant date: 2012.Concomitant medical products: therapy date: unknown, 183004 - femoral component - 640350, 141222 - tibial tray - j2503286, 183422 - bearing - 905590, 402282 - cobalt - ni, 402282 - cobalt - ni.The customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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: 0001822565-2021-00300, 0001822565-2021-00301, 0001822565-2021-00302.
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It was reported that patient underwent right total knee arthroplasty approximately 11 years ago.Subsequently, patient is experiencing pain and stiffness.The patient states that if she climbs the stairs more than a couple of times a day, she experience a lot of pain.She now lives downstairs and tries not to use the stairs.Attempts have been made and no further information has been provided.
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This follow-up report is being submitted to relay additional information.No devices were received; therefore the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-ray report provided by surgeon states that the prosthesis is in good alignment and patient has no fracture with presence of mild swelling noted.Additionally, in the findings there is a note of chronic appearing avoid ossicles superior and inferior to the patella and posterior to the joint line along with another calcification.These are of unknown origin.These may contribute to pain and stiffness.The report also notes that the patient recently struck the knee on wood.This could cause the swelling.Medical records were not provided.It was reported that the patient hit his knee to wood but we don¿t know what exactly caused it.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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