BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

    MDR report key: 17001453 · Received May 25, 2023

    Report

    Report Number
    3005180920-2023-00386
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    May 5, 2023
    Report Date
    May 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817519
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 1810587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2019. EXPIRATION DATE: 2024-FEB-11. 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 3 YEARS AFTER THE PRIMARY SURGERY, 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
    848655 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0320SCF 1810587 07630030817519

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention