BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEL-ONE CROSS-LINKED HYALURONATE

    MDR report key: 20797701 · Received November 26, 2024

    Report

    Report Number
    MW5162939
    Event Type
    Other
    Date Received
    November 26, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 24, 2024
    Manufacturer
    ZIMMER BIOMET/ SEIKAGAKU CORPORATION, TAKAHAGI PLANT
    Product Code
    MOZ
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED INJECTION OF GEL-ONE CROSS-LINKED HYALURONATE IN LEFT KNEE. PRIOR WAS RECEIVING CORTISONE AND CHANGED TO GEL-ONE INJECTION. AFTER THE NUMBING MEDICINE WORE OFF, MY KNEE WAS IN GREAT PAIN AND I COULD HARDLY WALK. NEEDED TO RETURN TO THE DOCTOR FOR ANOTHER CORTISONE INJECTION. THE GEL-ONE ACTUALLY MADE THE KNEE PAIN WORSE THAN WHEN I WENT IN. KNEE PAIN DUE TO DAMAGED MENISCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614537 GEL-ONE CROSS-LINKED HYALURONATE ACID, HYALURONIC, INTRAARTICULAR MOZ ZIMMER BIOMET/ SEIKAGAKU CORPORATION, TAKAHAGI PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female