BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 22962315 · Received September 4, 2025

    Report

    Report Number
    3005180920-2025-00831
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825606
    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 22 AUGUST 2025. GMK-HINGE 02.09.4005R GMK-HINGE TIBIAL TRAY - 5R (K130299) LOT. 2000774: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APRIL-2020. EXPIRATION DATE: 2025-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09.0517H GMK-HINGE TIBIAL INSERT - SIZE5 - 17 MM (K130299) LOT. 182058: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUNE-2018. EXPIRATION DATE: 2023-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-HINGE 02.09.2606R GMK-HINGE FEMORAL COMPONENT R - SIZE 6 (K130299) LOT 1905565: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2019. EXPIRATION DATE: 2024-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. 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 4 YEARS 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254748 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE TIBIAL TRAY - 5R KRO MEDACTA INTERNATIONAL SA 02.09.4005R 2000774 07630030825606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention