BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 22314129 · Received June 24, 2025

    Report

    Report Number
    3005180920-2025-00582
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    June 2, 2025
    Report Date
    June 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825057
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 JUN 2025 LOT 2402393: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAY-2024. EXPIRATION DATE: 2029-04-17. 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. ADDITIONAL COMPONENT INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 04 JUN 2025 GMK-HINGE 02.09. HE12 GMK-HINGE POST EXTENSION 12 MM -TINBN COATED ( K210010) LOT 2421663: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-SEPT-2024. EXPIRATION DATE: 2029-09-04. 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. 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 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND POST. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972027 GMK HINGE TOTAL KNEE SYSTEM FIXED TIBIAL INSERT SIZE 2/12MM KRO MEDACTA INTERNATIONAL SA 02.09.0212H 2402393 07630030825057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention