(b)(4).Concomitant medical products: catalog #: 00584201402, femoral component high flex precoat for cemented use only right medial/left lateral, lot # 60643098; catalog #: 00584200202, tibial component precoat right medial/left lateral size 2, lot # 60328072; catalog #: 00584305201, tibial tray / articular surface inserter tip, lot # 60455933; catalog #: 00579104100, headed screw 48 mm length single use only, lot # 60680747; catalog #: 00579104400, headed screw 33 mm length, lot # 60656749.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04814, 04849, and 04855.
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It was reported that the patient experienced pain, cysts, and swelling after a right total knee arthroplasty that she received after walking weirdly from a right hip replacement in which the doctor had to correct her leg length.Patient also gets cramps in her toes on the right leg.
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