(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2023-00109; 3007963827-2023-0011; 0002648920-2023-00085.D10-medical product: femur cemented (p) narrow right size 6 item# 42500006002 lot# 64729935; articular surface fixed bearing (cps) right 12 mm height item# 42522600512 lot# 64666743; all poly patella cemented 29 mm diameter item# 42540000029 lot# 64843522.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.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.
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