BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 7582501 · Received June 8, 2018

    Report

    Report Number
    3005180920-2018-00406
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    May 9, 2018
    Report Date
    June 8, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 160764: 81 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 78 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF LOOSENING. THE SURGEON DETERMINED THAT THE TIBIA WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. WHILE REMOVING THE TIBIAL COMPONENT, THE SURGEON KNOCKED THE FEMUR LOOSE. THE SURGEON REVISED THE TIBIA, FEMUR AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425384 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 160764 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention