BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2

    MDR report key: 13077259 · Received December 23, 2021

    Report

    Report Number
    3005180920-2021-01001
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 27, 2021
    Report Date
    December 23, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 NOVEMBER 2021: LOT 152801: 42 ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2015. EXPIRATION DATE: 2020-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALUATION: 6 YEARS AFTER PRIMARY CEMENTED TKA THE TIBIAL PLATEAU MIGRATES DISTALLY ON THE MEDIAL SIDE. NO TRAUMETIC EVENT IS REPORTED. IT IS VERY LIKELY THAT THE INCREASED AGE OF THE PATIENT LED TO WEAKENING OF THE BONE AND SUBSEQUENT MECHANICAL FAILURE OF THE PROXIMAL TIBIA. NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    THE TIBIA PLATEAU SANK INTO THE TIBIA BONE. THE REASON FOR THIS SINKING IS NOT KNOWN. THE KNEE WAS PAINFUL AND THEREFORE THE SURGEON DECIDED TO CHANGE TO A GMK HINGE 5 YEARS AND 11 MONTHS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972742 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1202R 152801 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention