BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 22042990 · Received May 19, 2025

    Report

    Report Number
    3005180920-2025-00435
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825453
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-APR-2025: LOT 2003428: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2020. EXPIRATION DATE: 25-MAY-2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2013. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION THAT WAS CAUSED FROM FALLING. THE SURGEON REMOVED ALL COMPONENTS AND CONVERTED THE PATIENT TO GMK-HINGE SYSTEM. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE FEMORAL COMPONENT AND INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167122 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE 02.09.2604L FEMORAL COMPONENT SIZE 4 L KRO MEDACTA INTERNATIONAL SA 02.09.2604L 2003428 07630030825453

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention