IBAL PATELLA IMPL DOME,37X 10 MM

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.

Description of Event or Problem

ON (B)(6) 2018 IT WAS REPORTED BY THE PATIENT, VIA THE ARTHREX WEBSITE, THAT HE UNDERWENT A BILATERAL TKA PROCEDURE ON (B)(6) 2013. TWO YEARS AFTER THE INITIAL SURGERY THE PATIENT BEGAN HAVING INSTABILITY AND PAIN IN BOTH KNEES (CC138269). ON (B)(6) 2018 A REVISION LEFT TKA PROCEDURE WAS PERFORMED BY THE SAME SURGEON DUE TO TIBIAL LOOSENING. ((B)(4), WHICH WAS REPORTED ON MEDWATCH 1220246-2018-00556). IT HAS NOW BEEN REPORTED THAT THE PATIENT HAD A RIGHT TKA REVISION ON (B)(6) 2019 BY THE SAME SURGEON AT A DIFFERENT FACILITY USING ANOTHER MANUFACTURER¿S PRODUCT. THE REVISION WAS PERFORMED DUE TO TIBIAL LOOSENING AND PAIN. THE ORIGINAL ARTHREX RIGHT TKA DEVICES WERE EXPLANTED AND THE PATIENT REQUESTED THEY BE RETURNED TO ARTHREX FOR EVALUATION. ARTHREX HAS NOT RECEIVED THE IMPLANTS TO DATE. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE (B)(6) 2019 REVISION: AR-503-TTTH, TIBIAL TRAY (LOT 108761238), AR-503-PSRJ FEMORAL IMPLANT (LOT 108761219), AR-503-BH10 BEARING IMPLANT (LOT 113601221), AR-504-PSD0 PATELLA IMPLANT (LOT 654468).