Description of Event or Problem · 1
MALE PATIENT UNDERWENT (TOTAL KNEE ARTHROPLASTY) TKA. PATIENT DID VERY WELL AND ON POSTOPERATIVE CHECK BY PHYSICIAN WAS DOING VERY WELL. HOWEVER, LATE IN THE EVENING, THE MANUFACTURING REPRESENTATIVE INDICATED TO THE SURGEON THAT THE IMPLANT (POLYETHYLENE INSERT) THAT WENT INTO THE KNEE WAS NOT THE REQUESTED IMPLANT THAT WAS REQUESTED BY THIS SURGEON AND CALLED FOR BASED ON THE SIZE OF THE TIBIA. WE DID EVALUATE THE FACT THAT THIS WAS A SIZE 71 POLY IN A SIZE 79 TRAY. THIS WAS EXPLAINED TO THE PATIENT AND THE WIFE AND THE SURGEON RECOMMENDED THE POLYETHYLENE BE EXCHANGED AT THE IDEAL TIME OF POSTOPERATIVELY DAY 1 OR AFTER THE WOUND WOULD BE COMPLETELY HEALED. DISCUSSION WAS HAD ABOUT LEAVING THE POLYETHYLENE AND WAITING UNTIL IT DID FAIL, WHICH THE SURGEON ADVISED AGAINST, BUT IT WAS AN ALTERNATIVE TREATMENT THAT WAS REVIEWED. ALSO DISCUSSED SPECIFIC RISKS AND POTENTIAL COMPLICATIONS. THE PATIENT HAD A SIZE 12 BY 79/83 CR LIPPED TIBIAL BEARING, BIOMET, WITH A MODULAR TIBIAL LOCKING BAR. THIS IS A NEW BAR, NOT THE BAR FROM THE PREVIOUS KNEE. NO OTHER IMPLANTS. REPLACEMENT SURGERY WAS CARRIED OUT.====================== MANUFACTURER RESPONSE FOR VANGUARD CR-LIPPED TIBIAL BEARING, BIOMET INC ORTHO SYSTEMS INC======================BIOMET REQUESTED A MEDWATCH REPORT BE FORWARDED TO THEM UPON COMPLETION.