BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM

    MDR report key: 18578852 · Received January 25, 2024

    Report

    Report Number
    3005180920-2024-00011
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825132
    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 09 JANUARY 2024 LOT 2242057: 15 ITEMS MANUFACTURED AND RELEASED ON 25-JAN-2023. EXPIRATION DATE: 2027-12-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 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 THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233287 GMK-HINGE FIXED TIBIAL INSERT SIZE 3/14MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 2242057 07630030825132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention