BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 23177252 · Received September 30, 2025

    Report

    Report Number
    3005180920-2025-00891
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    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 03 SEPT 2025: LOT 1904694: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2019. EXPIRATION DATE: 2024-JUN-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: 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 2 YEARS 5 MONTHS FROM 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945299 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE TIBIAL INSERT - SIZE3 - 17 MM KRO MEDACTA INTERNATIONAL SA 02.09.0317H 1904694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention