BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 11129983 · Received January 7, 2021

    Report

    Report Number
    3005180920-2021-00014
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 DECEMBER 2020: LOT 1810451: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 2024-03-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1 YEAR AND 7 MONTHS AFTER PRIMARY SURGERY, REPORTING INSTABILITY DUE TO A LOOSE TIBIAL COMPONENT. THE CAUSE OF THE LOOSE TIBIAL COMPONENT IS UNKNOWN. THE SURGEON REVISED THE TIBIAL COMPONENT, INSERT, AND ADDED AN EXTENSION STEM AND LATERAL TIBIAL AUGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27856 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1202L 1810451 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention