BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM

    MDR report key: 19080200 · Received April 10, 2024

    Report

    Report Number
    3005180920-2024-00211
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825293
    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 21 MARCH 2024: LOT 2200991: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2022. EXPIRATION DATE: 2027-MAY-19. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, 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
    407267 GMK-HINGE FIXED TIBIAL INSERT SIZE 5/20MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 2200991 07630030825293

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention