BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE INSTRUMENTS

    MDR report key: 21642256 · Received March 19, 2025

    Report

    Report Number
    3005180920-2025-00176
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630345713155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: 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.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2025. LOT 2162302: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAY-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE ISSUE WAS LIKELY INFLUENCED BY A COMBINATION OF THE INHERENT MECHANICAL LIMITATIONS OF THE DESIGN VERSION INVOLVED AND THE FORCES APPLIED UNDER THE SPECIFIC CONDITIONS OF USE.

    Description of Event or Problem · 0

    DURING THE COMPETITOR REVISION KNEE SURGERY, THE 5MM TRIAL OFFSET THREADED PIECE BROKE OUT OF CHASSIS. THE KEEL CAME OUT WITH THREADS ENGAGED INTO SMALL PIECE THAT CAME OUT OF OFFSET TRIAL, AND THE OFFSET TRIAL AND STEM WERE THEN STUCK IN TIBIAL CANAL. THE REP TRIED FOR 15-20 MIN TO FIND INSTRUMENTATION TO GRAB ONTO OFFSET TRIAL AND REMOVE FROM CANAL. THERE WAS A 20-MINUTE DELAY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562106 KNEE INSTRUMENTS GMK-REVISION 02.07.10.8652 TRIAL OFFSET 5MM LXH MEDACTA INTERNATIONAL SA 02.07.10.8652 2162302 07630345713155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other