BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE

    MDR report key: 21111586 · Received January 9, 2025

    Report

    Report Number
    3004371426-2025-00001
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 10, 2024
    Report Date
    December 10, 2024
    Manufacturer
    WALDEMAR LINK GMBH & CO. KG
    Product Code
    KRO
    UDI-DI
    04026575319015
    PMA / PMN Number
    K143179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE HISTORY RECORD SHOWED NO DEVIATIONS. THE PRODUCT COMPLIES WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURE. THIS IS THE FINAL SUPPLEMENTAL REPORT. THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    SIDE: LEFT. DIAGNOSIS: FEMORAL SHAFT FRACTURE WITH POSSIBLE METALLOSIS? REVISION OF THE CEMENTED 120MM FEMORAL SHAFT, THE SIZE M FEMORAL COMPONENT, THE SIZE 3 FEMORAL SEGMENT AND THE TIBIAL PLATEAU. THE TIBIA WAS FIRMLY ANCHORED. THE FEMORAL SHAFT IS BROKEN OR FRAGMENTED AT THE DISTAL END OR AT THE ATTACHMENT TO THE FEMORAL CONE IN SEVERAL PLACES. REMOVAL OF THE SHAFT WAS DIFFICULT BECAUSE NO LOOSENING WAS DETECTABLE. THE HOLE FOR SCREW FIXATION WAS WIDENED WITH A DRILL TO ALLOW A REMOVAL HOOK TO BE ATTACHED AND THE STEM TO BE REMOVED WITH A HAMMER. AFTER REMOVAL OF THE STEM, IRRIGATION AND INSERTION OF LOW-VISCOSITY CEMENT, THE FOLLOWING WAS IMPLANTED: FEMORAL COMPONENT 15-2817/12 REPLACEMENT PLATEAU 150027/15 MODULAR STEM 15-2950/06 FEMORAL SEGMENT 15-2978/02 A VERY SATISFACTORY RESULT WAS ACHIEVED.[CUSTOMER].

    Description of Event or Problem · 0

    SIDE: LEFT. DIAGNOSIS: FEMORAL SHAFT FRACTURE WITH POSSIBLE METALLOSIS? REVISION OF THE CEMENTED 120MM FEMORAL SHAFT, THE SIZE M FEMORAL COMPONENT, THE SIZE 3 FEMORAL SEGMENT AND THE TIBIAL PLATEAU. THE TIBIA WAS FIRMLY ANCHORED. THE FEMORAL SHAFT IS BROKEN OR FRAGMENTED AT THE DISTAL END OR AT THE ATTACHMENT TO THE FEMORAL CONE IN SEVERAL PLACES. REMOVAL OF THE SHAFT WAS DIFFICULT BECAUSE NO LOOSENING WAS DETECTABLE. THE HOLE FOR SCREW FIXATION WAS WIDENED WITH A DRILL TO ALLOW A REMOVAL HOOK TO BE ATTACHED AND THE STEM TO BE REMOVED WITH A HAMMER. AFTER REMOVAL OF THE STEM, IRRIGATION AND INSERTION OF LOW-VISCOSITY CEMENT, THE FOLLOWING WAS IMPLANTED: FEMORAL COMPONENT 15-2817/12. REPLACEMENT PLATEAU 150027/15. MODULAR STEM 15-2950/06. FEMORAL SEGMENT 15-2978/02. A VERY SATISFACTORY RESULT WAS ACHIEVED. [(B)(6)].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417713 ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE ENDO-MODEL -M, MODULAR STEMS, CEMENTED, COCRMO, CONICAL, L= 120MM, Ø=16 MM KRO WALDEMAR LINK GMBH & CO. KG 15-2950/04 1128111 04026575319015

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention