CANARY CANTURIO TIBIAL EXTENTION

Description of Event or Problem

CANARY MEDICAL RECEIVED A COMPLAINT NOTIFICATION ON SEPTEMBER 7, 2023. ZIMMER BIOMET SALES REP REPORTED THAT A PERIPROSTHETIC FEMORAL FRACTURE HAD OCCURRED IN A PATIENT AND RESULTED IN REVISION SURGERY ON (B)(6) 2023. THE EVENT WAS NOT REPORTED TO CANARY UNTIL (B)(6) 2023. THE REPORTER INDICATED THAT A PART OF PERSONA IQ; MANUFACTURER: ZIMMER BIOMET AND THE CANARY CANTURIO TIBIAL EXTENSION (CTE) WERE REMOVED DURING REVISION SURGERY. CANARY FOLLOWED UP WITH THE SALES REP AND COMPLAINT REP FROM ZIMMER BIOMET WITH ADDITIONAL QUESTIONS REGARDING THE PATIENT AND EVENT. CANARY RECEIVED A SURGICAL PHOTO OF THE PERSONA IQ AND CANARY CTE WITH NO ADDITIONAL INFORMATION PROVIDED. CANARY RECEIVED CONFIRMATION THAT ZIMMER BIOMET FILED A MDR UNDER REPORT NUMBER 0001822565-2023-01579. THE CTE WAS NOT RETURNED TO CANARY MEDICAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CANARY IS FILING A MDR FOR DEATH OR SERIOUS INJURY HOWEVER, THE MDR DECISION WAS BASED ON LACK OF INFORMATION REGARDING THE CAUSE OF THE EVENT. REFERENCE REPORT: MW5146159.