BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 9493947 · Received December 19, 2019

    Report

    Report Number
    3005180920-2019-01071
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 25, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 DECEMBER 2019: LOT 1810451: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2019. EXPIRATION DATE: 05-MAR-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 COMPLAINING OF PAIN CAUSED BY A LOOSE TIBIAL TRAY 5 MONTHS AFTER . THE PATIENT WAS VALGUS PHYSICALLY AND WAS HYPEREXTENDED. THE SURGEON REVISED THE INSERT AND TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287157 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 1810451 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention