BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 11907349 · Received May 31, 2021

    Report

    Report Number
    3005180920-2021-00462
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 31, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    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 31 MAY 2021: LOT 162180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2016. EXPIRATION DATE: 2021-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THIS LOT SINCE 2017.

    Description of Event or Problem · 1

    4 YEARS 6 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN REPORTING PAIN DUE TO A COLLAPSED TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803156 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1205L 162180 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention