(b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2024-00084.D10 medical devices: persona tibia cemented 5 degree stemmed right size d catalog#:42532006702 lot#: 64979445 persona articular surface fixed bearing posterior stabilized (ps) right 10 mm height catalog#: 42522400510 lot#: 64788388.Biomet bc r 1x40 us catalog#: 110035368 lot#: az50ba2102.Customer has indicated that the product will not 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.
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It was reported that patient underwent an initial right total knee arthroplast.Subsequently, the patient has experienced ongoing pain, swelling, and heat in the joint.Allergy testing indicated reactivity to certain elements contained in the implants.The patient requested material analysis for this correlation and has not expressed an intent to pursue further medical or surgical intervention at this time.
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