BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 23120983 · Received September 23, 2025

    Report

    Report Number
    3005180920-2025-00872
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    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 (B)(6) 2025. 02.09.0217H GMK-HINGE TIBIAL INSERT - SIZE2 - 17 MM (K130299) LOT 2336372: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-11-2023 EXPIRATION DATE: 2028-11-05. 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. 02.09.HE17 GMK-HINGE POST EXTENSION 17 MM -TINBN COATED (K210010) LOT 2429181: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-02-2025 EXPIRATION DATE: 2030-01-13. 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

    AT ABOUT 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND POST. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200776 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE TIBIAL INSERT - SIZE2 - 17 MM KRO MEDACTA INTERNATIONAL SA 02.09.0217H 2336372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention