IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL

Additional Manufacturer Narrative

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON 08/08/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT DURING A MEDIAL UNI-COMPARTMENTAL KNEE REPLACEMENT A AR-501-UFLD IBALANCE¿ UKA FEMORAL,CEMENTED SIZE 4S THE CEMENT BECAME TO FIRM WHEN TRYING TO IMPLANT THE FEMORAL COMPONENT. NOT BEING ABLE TO FULLY SEAT THE FEMORAL COMPONENT, THE COMPONENT WAS THEN REMOVED AS WELL AS THE CEMENT REMOVED AND A NEW BATCH OF CEMENT MIXED. A 2ND COMPONENT WAS OPENED, AS ALL THE PRIOR CEMENT COULD NOT BE REMOVED FROM THE ORIGINAL IMPLANT. IT WAS ALSO FOUND THAT THE TIBIAL ACL INSERTION HAD AVULSED, THAT WAS REPAIRED BACK DOWN TO THE TIBIA WITH A 4.5 CANNULATED SCREW AND WASHER, AS WELL AS A FIBERTAPE FIXATED WITH A SWIVELOCK INTO THE PROXIMAL TIBIA. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED.

Additional Manufacturer Narrative

VISUAL INSPECTION FOUND ON THE PROXIMAL SIDE OF THE DEVICE A SIGNIFICANT AMOUNT OF CEMENT ON THE DEVICE. THE HARDENING OF THE CEMENT IS AN EXPECTED PROCESS. POSSIBLE CAUSES OF THE CEMENT HARDENING INCLUDE MISUSE OF THE DEVICE LEAVING SIGNIFICANT TIME FOR THE CEMENT TO CURE BEFORE SEATING OF THE DEVICE WAS ATTEMPTED OR THE CEMENT POSSIBLY CURED FASTER THAN EXPECTED. HOWEVER, NO ISSUES WERE NOTED WITH AR-501-UFLD. COMPLAINT WAS NOT CONFIRMED.