BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANTURIO TIBIAL EXTENSION W/CHIRP

    MDR report key: 20311744 · Received September 25, 2024

    Report

    Report Number
    MW5160105
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 6, 2024
    Manufacturer
    CANARY MEDICAL USA LLC
    Product Code
    QPP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 11/6/2024 FOR REPORT MW5160105 TO UPDATE PROCODE TO QPP.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED FROM CLINICAL MONITORING OF THE 522 POST MARKET SURVEILLANCE STUDY. THE SITE NOTED THAT THE PATIENT RECEIVED TOTAL KNEE ARTHROPLASTY ON (B)(6) 2024 AND THEN DEVELOPED IMPAIRED RANGE OF MOTION AND UNDERWENT MANIPULATION UNDER ANESTHESIA ON (B)(6) 2024. THE SITE NOTED THAT THE ADVERSE EVENT IS "POSSIBLY RELATED" TO THE DEVICE AND THE ADVERSE EVENT IS "DEFINITELY RELATED" TO THE TOTAL KNEE ARTHROPLASTY. CANARY MEDICAL FOLLOWED UP WITH THE SITE WITH ADDITIONAL QUESTIONS. CANARY MEDICAL ASKED IF THE EVENT HAS BEEN RESOLVED. THE SITE'S RESPONSE IS, THE EVENT IS STILL UNRESOLVED AND THE FIRST FOLLOW-UP AFTER THE MANIPULATION UNDER ANESTHESIA IS SCHEDULED FOR (B)(6) 2024, WHERE THE SITE WILL REASSESS THE PATIENT'S RANGE OF MOTION TO CHECK FOR IMPROVEMENT. CANARY MEDICAL ALSO VERIFIED WITH THE SITE THAT THE CANTURIO TIBIAL EXTENSION IS FUNCTIONAL POST MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830873 CANTURIO TIBIAL EXTENSION W/CHIRP IMPLANTABLE POST-SURGICAL KINEMATIC MEASUREMENT KNEE DEVICE QPP CANARY MEDICAL USA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other