BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L LOT. 2000558

    MDR report key: 17276803 · Received July 7, 2023

    Report

    Report Number
    3005180920-2023-00480
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 JUNE 2023. LOT 2000558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MARCH-2020. EXPIRATION DATE: 2025-03-08. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DÉPARTEMENT. ABOUT 2 YEARS AFTER PRIMARY CEMENTED TKA THE TIBIAL COMPONENT GETS LOOSE AND NEEDS REPLACEMENT. THERE IS NO INDICATION, IN THE INFORMATION RECEIVED, THAT THE LOOSENING MAY BE DUE TO A DEFECT IN THE IMPLANTED COMPONENTS, AND FROM THE IMAGES RECEIVED WE CANNOT IDENTIFY A CLEAR CAUSE. ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING TKA, REPORTED IN LITERATURE AND MENTIONED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 4 MONTHS AFTER THE PRIMARY, REVISION SURGERY FOR CEMENTED TIBIAL TRAY LOOSENING. THE SURGEON REVISED SUCCESSFULLY. THE SYSTEM TO REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040579 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L LOT. 2000558 KNEE TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.1204L 2000558 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention