BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 25242297 · Received May 21, 2026

    Report

    Report Number
    3005180920-2026-00460
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825156
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MAY 2026 LOT 2110197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEPT-2021. EXPIRATION DATE: 2026-SEPT-09. 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. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2023, THE PATIENT WAS REVISED TO MEDACTA GMK-HINGE IMPLANTS. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-HINGE TIBIAL INSERT SIZE 3 - 20MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62622 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE TIBIAL INSERT - SIZE3 - 20 MM KRO MEDACTA INTERNATIONAL SA 02.09.0320H 2110197 07630030825156

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention