BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANARY CANTURIO TIBIAL EXTENTION

    MDR report key: 17824566 · Received September 26, 2023

    Report

    Report Number
    MW5146158
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    May 17, 2023
    Report Date
    September 19, 2023
    Manufacturer
    CANARY MEDICAL USA LLC
    Product Code
    QPP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099252 CANARY CANTURIO TIBIAL EXTENTION IMPLANTABLE POST-SURGICAL KINEMATIC MEASUREMENT KNEE DEVICE QPP CANARY MEDICAL USA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Prefer Not To Disclose Other| R