BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 2/12MM

    MDR report key: 17831881 · Received September 28, 2023

    Report

    Report Number
    3005180920-2023-00755
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 6, 2023
    Report Date
    September 28, 2023
    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 11 SEPTEMBER 2023: LOT: 2118876: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2022. EXPIRATION DATE: 2027-05-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY 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
    1976142 GMK-HINGE FIXED TIBIAL INSERT SIZE 2/12MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 2118876 07630030825057

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention