BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINK ENDO-MODEL ROTATIONAL KNEE SYSTEM MODULAR

    MDR report key: 3177051 · Received June 7, 2013

    Report

    Report Number
    9610548-2013-00003
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 22, 2013
    Report Date
    June 10, 2013
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    PMA / PMN Number
    K821476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATIONS OF RETURNED GOODS SHOWS THAT THE UHMWPE BUSHING PLUG PARTIALLY SHOWS THE FAILURE OF COMPLAINT DESCRIPTION AS WELL AS THAT IT IS HARD TO ASSEMBLE OR RE-ASSEMBLE THE POLY PLUG IN THE CORRECT POSITION. RISK ASSESSMENT: INITIAL IMPLANTATION OF THE FEMORAL SEGMENT WITHOUT POLY PLUG. THE POLY PLUG COVERS THE ROTATION MECHANISM AGAINST BONE CEMENT. WITHOUT THE POLY PLUG, THERE MIGHT BE A RISK TO OBSTRUCT THE ROTATING MECHANISM, WHICH WILL LEAD TO A LIMITED FUNCTION OF THE KNEE JOINT AND A REVISION SURGERY. IN CASE OF A REVISION SURGERY OF AN IMPLANTED FEMORAL SEGMENT WITHOUT POLY PLUG (EXCHANGE OF THE ROTATING MECHANISM) THERE IS NO RISK. THE AXIS OF THE ROTATING MECHANISM WILL BE REPLACED DIRECTLY. NO NEW BONE CEMENT IS USED FOR THIS TASK. IN CASE OF A REVISION SURGERY OF AN IMPLANTED FEMORAL SEGMENT WITH JAMMED POLY PLUG (EXCHANGE OF THE ROTATING MECHANISM) THERE IS NO RISK. THE JAMMED POLY PLUG CAN BE DRILLED OUT AND THE ROTATING MECHANISM WILL BE REPLACED DIRECTLY. NO NEW BONE CEMENT IS USED FOR THIS TASK. THE REASON WHICH LEADS TO THIS COMPLAINT IS UNDER INVESTIGATION. WE ARE CHECKING THE WORKING AND TEST INSTRUCTIONS. BESIDE THIS A DIMENSIONAL TOLERANCE AND INTERFACE CHECK WILL BE PERFORMED. THIS EVENT OCCURRED OUTSIDE OF THE U.S. AND INVOLVED A PRODUCT THAT WAS MANUFACTURED OUTSIDE OF THE U.S.

    Description of Event or Problem · 1

    WHEN THIS IMPLANT WAS OPENED AND ALREADY IN THE HAND OF THE SURGEON HE NOTICED THAT THE POLY BUSHING PLUG WAS NOT SEATED CORRECTLY AND WAS PROTRUDING INTO THE JOINT SPACE. THE SURGEON TRIED TO PUSH IT IN FURTHER BUT WAS NOT SUCCESSFUL SO HE DISCARDED THIS IMPLANT. HE THEN OPENED A SPARE IMPLANT OF THE SAME SIZE FROM A DIFFERENT BATCH (REF 15-2978-01, SN (B)(4), EXP 02/01/2017) AND THEN FOUND THE SAME PROBLEM ON THE OPPOSITE. ON THIS IMPLANT THE POLY PLUG HAD BEEN PUSHED TOO FAR IN AND WAS OBSTRUCTING THE IMPLANT SITTING ONTO THE BOX OF THE FEMORAL COMPONENT. AT THIS POINT HE DIDN'T HAVE A SPARE IMPLANT SO THE SURGEON HAD TO USE A HAMMER TO PUSH THIS BUSHING COVER OUT COMPLETELY AND THEN REPLACE IN THE CORRECT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253992 LINK ENDO-MODEL ROTATIONAL KNEE SYSTEM MODULAR FEMORAL SEGMENT, ROTATIONAL KNEE MODULAR KRO WALDEMAR LINK GMBH & CO. KG 12-2978/01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R