BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L

    MDR report key: 16589561 · Received March 22, 2023

    Report

    Report Number
    3005180920-2023-00158
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    February 20, 2023
    Report Date
    March 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819384
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-FEB-2023. LOT: 1905611: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2019. EXPIRATION DATE: 2024-12-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AND 9 MONTHS AFTER THE PREVIOUS REVISION SURGERIES, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE TIBIA AND INSERT. THIS IS THE 4TH REVISION SURGERY FOR THIS PATIENT. THE FIRST ONE WAS PERFORMED DUE TO LAXITY CAUSED BY A FALL AND THE INSERT WAS REVISED. THE SECOND REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY (REVISED THE INSERT AND TIBIAL TRAY). THE THIRD REVISION SURGERY WAS PERFORMED DUE TO A LOOSE TIBIAL TRAY CAUSED BY A TRAUMA (REVISION OF INSERT AND TIBIAL TRAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450519 GMK-REVISION 02.07.0684L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 L KNEE REVISION FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.0684L 1905611 07630030819384

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention