BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 18020319 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00847
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 OCTOBER 2023. LOT 113791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2011. EXPIRATION DATE: 2016-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS 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 11 YEARS 6 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO A LOOSE CEMENTED TIBIAL TRAY FIXED. THE SURGEON OBSERVED THAT THE COBALT CEMENT SEEMED TO BE THE LOOSENING FACTOR. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151301 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 113791 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention