IBAL PATELLA IMPL DOME,37X 10 MM

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THEREFORE THE ALLEGED COMPLAINT EVENT COULD NOT BE CONFIRMED. THE FAILURE MODE REPORTED BY THE CUSTOMER IS A KNOWN FAILURE MODE, AND AS NO DEVICE HAS BEEN RECEIVED FROM THE COMPLAINANT, NO INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem

IT WAS REPORTED BY THE PATIENT THAT HE HAD TOTAL KNEE RECONSTRUCTION ON 4-22-15. ABOUT TWO YEARS AGO THE PATIENT STARTED EXPERIENCING PAIN IN THE KNEE. PER THE PATIENT, X-RAYS WERE TAKEN AND IT WAS DETERMINED THE KNEE IS NOW LOOSE. PATIENT IS SCHEDULED FOR A REVISION LEFT TKA SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION OBTAINED 10/10/2019: THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE ON (B)(6) 2015. PATIENT REPORTED THAT BONE SCANS WERE TAKEN WHICH CONFIRMED HIS LEFT TIBIAL IMPLANT TO BE LOOSE. PATIENT STATED HE HAS DEALT WITH THE PAIN AND ACCOMPANYING ISSUES FOR OVER TWO YEARS, TAKING 1000 MG OF TYLENOL AND 800 MG OF IBUPROFEN DAILY OVER PAST SEVERAL YEARS, BUT REPORTS HIS LEG IS NOW BOWED AND CAUSING SCIATICA TYPE PAIN IN HIS HIP. DURING THE (B)(6) 2015 ORIGINAL PROCEDURE THE PATIENT HAD THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED IN HIS LEFT KNEE: AR-503-TTTH, TIBIAL TRAY IMPLANT (LOT 1358298). AR-516-7L, FEMORAL IMPLANT (LOT 1373719). AR-513-BH12, BEARING IMPLANT (LOT 113601409). AR-504-PSD0, PATELLA IMPLANT (LOT 113601430). ADDITIONAL INFORMATION OBTAINED 11/19/2019: CONFIRMATION WAS RECEIVED THAT THE PATIENT'S LEFT TKA REVISION PROCEDURE TOOK PLACE AS SCHEDULED ON (B)(6) 2019. ALL ORIGINAL LEFT TKA COMPONENTS WERE EXPLANTED AND ANOTHER MANUFACTURER'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE EXPLANTED DEVICES WERE RETAINED BY THE PATIENT.