BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK HINGE TRIAL OFFSET 5MM

    MDR report key: 18491228 · Received January 11, 2024

    Report

    Report Number
    3005180920-2023-01054
    Event Type
    Malfunction
    Date Received
    January 11, 2024
    Date of Event
    December 12, 2023
    Report Date
    February 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630345713155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION FOLLOWING REQUEST OF FDA AND REPORTED WITH THIS FU: - PRODUCT CODE CHANGED IN LXH. BEFORE IT WAS WRONGLY INSERTED LHX..

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 JANUARY 2024 LOT 2259675: 27 ITEMS MANUFACTURED AND RELEASED ON 05-APR-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. ANALYSIS PERFORMED BY R&D MANAGER: THE PERFORMED ANALYSIS CONFIRMED THAT THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET HAS BEEN DISASSEMBLED FROM THE MAIN BODY DURING TRIAL REMOVAL FROM THE BONE. DURING EXTRACTION OF THE SYSTEM CONSISTING OF EXTENSION STEM, TRIAL OFFSET AND TRIAL KEEL ASSEMBLY FROM THE BONE, THE ELASTIC CLIPPING OF THE THREADED INSERT OF THE TRIAL OFFSET IS UNABLE TO WITHSTAND THE BLOWS AND DISENGAGES FROM THE OFFSET BODY ITSELF.

    Description of Event or Problem · 0

    THE ANTI-ROTATIONAL INSERT OF THE TRIAL OFFSET BROKE. THE OFFSET TRIAL AND THE STEM WERE BLOCKED IN THE INTRAMEDULLARY CANAL. THE BROKEN PART WAS REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424685 GMK HINGE TRIAL OFFSET 5MM REUSABLE INSTRUMENT FOR KNEE SURGERIES LXH MEDACTA INTERNATIONAL SA 2259675 07630345713155
    954508 GMK HINGE TRIAL OFFSET 5MM REUSABLE INSTRUMENT FOR KNEE SURGERIES LXH MEDACTA INTERNATIONAL SA 2259675 07630345713155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention