BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO MODEL M

    MDR report key: 20189657 · Received September 11, 2024

    Report

    Report Number
    3004371426-2024-00061
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 14, 2024
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    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

    NOTIFIED BY (B)(6). THAT ON (B)(6) 2024, DR. (B)(6). WAS PERFORMING A REVISION USING THE ENDO W HINGE SYSTEM AND 2 LOTS OF TIBIAL AUGMENTS WERE OPENED AND EACH HAD A SCREW THAT WOULD NOT DISENGAGE. CEMENT WAS THEN USED TO SET THE AUGMENT IN PLACE. ON PART 15-2814/02 LOT 230619/2153, ONLY THE LATERAL SCREW COULD BE REMOVED. ON PART 15-2814/02 LOT 230703/1306, ONLY THE MEDIAL SCREW COULD BE REMOVED. IT WAS ALSO NOTED THAT THE SCREWS THAT WERE REMOVED WERE VERY DIFFICULT TO GET OUT, AND A 2.5 SCREWDRIVER WAS BROKEN IN THE PROCESS. LOT 230703/1306 WAS CEMENTED INTO PLACE. WAITING INFORMATION ON RETURN OF LOT 230619/2153. CORRECTION 2024-08-21: INITIAL PN / LOT NUMBER INFORMATION RECEIVED WAS INACCURATE. I HAVE RECEIVED THE COMPLAINT SAMPLE AND IT IS LOT 230703/1306, SO LOT 230619/2153 IS THE PART THAT HAS BEEN IMPLANTED, WHICH WAS VERIFIED BY THE REPRESENTATIVE. COMPLAINT SAMPLE WILL BE SHIPPED FOR INVESTIGATION. [CUSTOMER]

    Description of Event or Problem · 0

    NOTIFIED BY T. A. THAT ON (B)(6) 2024, DR. D. WAS PERFORMING A REVISION USING THE ENDO W HINGE SYSTEM AND 2 LOTS OF TIBIAL AUGMENTS WERE OPENED AND EACH HAD A SCREW THAT WOULD NOT DISENGAGE. CEMENT WAS THEN USED TO SET THE AUGMENT IN PLACE. ON PART 15-2814/02 LOT 230619/2153, ONLY THE LATERAL SCREW COULD BE REMOVED. ON PART 15-2814/02 LOT 230703/1306 , ONLY THE MEDIAL SCREW COULD BE REMOVED. IT WAS ALSO NOTED THAT THE SCREWS THAT WERE REMOVED WERE VERY DIFFICULT TO GET OUT, AND A 2.5 SCREWDRIVER WAS BROKEN IN THE PROCESS. LOT 230703/1306 WAS CEMENTED INTO PLACE. WAITING INFORMATION ON RETURN OF LOT 230619/2153. CORRECTION 2024-08-21:INITIAL PN / LOT NUMBER INFORMATION RECEIVED WAS INACCURATE. I HAVE RECEIVED THE COMPLAINT SAMPLE AND IT IS LOT 230703/1306, SO LOT 230619/2153 IS THE PART THAT HAS BEEN IMPLANTED, WHICH WAS VERIFIED BY THE REPRESENTATIVE. COMPLAINT SAMPLE WILL BE SHIPPED FOR INVESTIGATION. [CUSTOMER].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600886 ENDO MODEL M MOD.ROTATIONKNEE, TIBIAL COMP.,SMALL, NEUTRAL KRO WALDEMAR LINK GMBH & CO. KG 15-2814/02 04026575316281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female