BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM

    MDR report key: 18806017 · Received February 29, 2024

    Report

    Report Number
    3005180920-2024-00087
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817298
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 FEBRUARY 2024. LOT 172162: (B)(4) MANUFACTURED AND RELEASED ON 23-OCT-2017. EXPIRATION DATE: 2022-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 5 YEARS 4 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
    444646 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 172162 07630030817298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention