BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/23MM

    MDR report key: 12039382 · Received June 22, 2021

    Report

    Report Number
    3005180920-2021-00520
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 22, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818134
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 08.JUNE.2021: LOT 2003170: 25 ITEMS MANUFACTURED AND RELEASED ON 3-AUG-2020. EXPIRATION DATE: 2025-07-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    2 DAYS AFTER THE PREVIOUS REVISION SURGERY (DUE TO INFECTION) THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942899 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/23MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0423SCF 2003170 07630030818134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention