BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENIUS TOTAL KNEE SYSTEM

    MDR report key: 8145383 · Received December 9, 2018

    Report

    Report Number
    3008262872-2018-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 10, 2018
    Manufacturer
    SIGNATURE ORTHOPAEDICS PTY LTD
    Product Code
    JWH
    UDI-DI
    09348215020309
    PMA / PMN Number
    K170613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT RECORDS HAVE BEEN REVIEWED AND NO FURTHER COMPLAINTS HAVE BEEN IDENTIFIED WITH THE SUBJECT DEVICE BATCH. THE DHR HAS BEEN REVIEWED AS PART OF THE INVESTIGATION. IT WAS FOUND THAT THE MIXED PRODUCTS WERE PROCESSED AT THE SAME TIME. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO PREVENT REOCCURRENCE.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED BY SIGNATURE ORTHOPAEDICS PTY LTD ON (B)(6) 2018 FROM SIGNATURE ORTHOPAEDICS USA REPRESENTATIVE STATING: "SIGNATURE US SALE REPRESENTATIVE REPORTED THAT OPENED SIZE 4 TIBIA BOX (121-07-4004) AND TO MY SURPRISE THERE WAS A SIZE 0 LEFT FEMUR (121-07-3000) IN THERE. ALSO THE STICKER WAS FOR SIZE 4 TIBIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984684 GENIUS TOTAL KNEE SYSTEM TOTAL KNEE PROSTHESIS JWH SIGNATURE ORTHOPAEDICS PTY LTD 121-07-4004 77A3F 09348215020309

    Patients

    Seq Age Sex Outcome Treatment
    1