BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO MODEL M

    MDR report key: 18694248 · Received February 13, 2024

    Report

    Report Number
    3004371426-2024-00019
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 23, 2024
    Report Date
    January 24, 2024
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    HRY
    UDI-DI
    04026575316281
    PMA / PMN Number
    K143179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FINAL SUPPLEMENTAL REPORT, THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    DR. (B)(6) WAS USING AN ENDO MODEL M TIBIAL COMPONENT (B)(6) AND ONE OF THE BLIND SCREWS FOR ATTACHING THE AUGMENT COULD NOT BE REMOVED AND THE HEAD GOT STRIPPED. A SECOND TIBIAL COMPONENT WAS OPENED AND A NEW SCREWDRIVER WAS USED BUT THIS ALSO HAD ONE SCREW THAT WAS LOCKED AND COULD NOT BE REMOVED, LEADING TO THIS SCREW HEAD BECOMING STRIPPED AS WELL. THE AUGMENT USED WAS THEN CEMENTED IN PLACE AND THE SECOND TIBIAL COMPONENT WAS IMPLANTED. SURGERY TIME WAS EXTENDED APPROXIMATELY 15 MINUTES. NOTE: THE SECOND TIBIAL COMPONENT IS WITHIN THE SCOPE OF RECALL R-2022-01, BUT THE FIRST TIBIAL COMPONENT WHICH WAS OPENED, AND DISPLAYED THE SAME ISSUE AS THE TIBIAL COMPONENTS WITHIN THE SCOPE OF THAT RECALL, WAS MANUFACTURED IN DEC 2022, AND THEREFORE IS OUTSIDE THE SCOPE OF THAT RECALL. [CUSTOMER].

    Description of Event or Problem · 0

    DR. (B)(6) WAS USING AN ENDO MODEL M TIBIAL COMPONENT (220808/2706) AND ONE OF THE BLIND SCREWS FOR ATTACHING THE AUGMENT COULD NOT BE REMOVED AND THE HEAD GOT STRIPPED. A SECOND TIBIAL COMPONENT WAS OPENED AND A NEW SCREWDRIVER WAS USED BUT THIS ALSO HAD ONE SCREW THAT WAS LOCKED AND COULD NOT BE REMOVED, LEADING TO THIS SCREW HEAD BECOMING STRIPPED AS WELL. THE AUGMENT USED WAS THEN CEMENTED IN PLACE AND THE SECOND TIBIAL COMPONENT WAS IMPLANTED. SURGERY TIME WAS EXTENDED APPROXIMATELY 15 MINUTES. NOTE: THE SECOND TIBIAL COMPONENT IS WITHIN THE SCOPE OF RECALL R-2022-01, BUT THE FIRST TIBIAL COMPONENT WHICH WAS OPENED, AND DISPLAYED THE SAME ISSUE AS THE TIBIAL COMPONENTS WITHIN THE SCOPE OF THAT RECALL, WAS MANUFACTURED IN DEC 2022, AND THEREFORE IS OUTSIDE THE SCOPE OF THAT RECALL. [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278985 ENDO MODEL M ENDO-M. MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL HRY WALDEMAR LINK GMBH & CO. KG 15-2814/02 04026575316281

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female