BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 11670135 · Received April 15, 2021

    Report

    Report Number
    3005180920-2021-00292
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    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 22 MARCH 2021: LOT 173670: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEP-2017. EXPIRATION DATE: 2022-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN DUE TO TIBIAL LOOSENING AND THE CAUSE OF THE TIBIAL LOOSENING IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT 3 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569049 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 02.07.1203L 173670 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention