BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT

    MDR report key: 15258812 · Received August 19, 2022

    Report

    Report Number
    3005180920-2022-00626
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 19, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED ON 19-AUG-2022: ONE YEAR AFTER PRIMARY CEMENTED TKA, JOINT INSTABILITY REQUIRES TO EXCHANGE THE TIBIAL INSERT TO A THICKER ONE. SECONDARY DEVELOPMENTAL INSTABILITY IS A KNOWN, POSSIBLE PROGRESSION OF DISEASE FOLLOWING TKA, DESCRIBED IN LITERATURE. IN MANY CASES, A THICKER INSERT CAN SOLVE THE PROBLEM, IF THE LIGAMENT LAXITY STOPS FROM PROGRESSING FURTHER. THIS REOPERATION WAS NOT DUE TO A DEFECTIVE DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY. THE SURGEON REVISED THE INSERT (10MM TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791041 GMK-SPHERE TIBIAL INSERT KNEE TIBIAL INSERT JWK MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention