U2 TOTAL KNEE SYSTEM

Description of Event or Problem

DURING A TOTAL KNEE ARTHROPLASTY SURGERY (TO REMOVE NON-UNITED PRODUCT AND IMPLANT UNITED PRIMARY KNEE IMPLANTS), THE PATIENT'S FEMUR FRACTURED WHILE THE SURGEON WAS IMPACTING THE FEMORAL IMPLANT CONSTRUCT. IT IS REPORTED THAT THE PATIENT BONE WAS IN POOR BONE CONDITION. AS A RESULT OF THE FRACTURE, THE SURGEON HAD TO REMOVE ALL SEVEN OF THE PRIMARY KNEE IMPLANTS AND CHANGE THE SURGICAL APPROACH. THE PROCEDURE WAS CONVERTED TO A DISTAL FEMUR REPLACEMENT (DFR) TO ADDRESS BOTH THE ORIGINAL BONE QUALITY AND THE FRACTURE. THE SURGEON COMPLETED THE SURGERY BY IMPLANTING THE DFR IMPLANTS. THE AGENT WHO WAS PRESENT DURING THE SURGERY PROVIDED FEEDBACK THAT THE PATENT IS REPORTED TO BE DOING WELL AND CLINICAL OUTCOME IS POSITIVE. THE HOSPITAL HAD DISPOSED THE EXPLANTED IMPLANTS AS THERE WAS BIOBURDEN AND CEMENT AND THEY ARE NOT AVAILABLE FOR ANALYSIS. AGENT PROVIDED FEEDBACK THAT UNITED ORTHOPEDIC IMPLANTS DID NOT CAUSE THE PATIENT BONE TO FRACTURE, FRACTURE WAS CAUSED DUE TO PATIENTS POOR BONE CONDITION. SUBMITTING THIS MDR AS UNITED PRODUCT WAS PRESENT DURING THE SURGERY.