BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM

    MDR report key: 12126586 · Received July 7, 2021

    Report

    Report Number
    3005180920-2021-00559
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817175
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 JUNE 2021: LOT 1904796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2019. EXPIRATION DATE: 2024-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    1 MONTH AFTER THE PRIMARY SURGERY 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
    1026330 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0312SCF 1904796 07630030817175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention