BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC-ONE

    MDR report key: 8339484 · Received February 13, 2019

    Report

    Report Number
    MW5084064
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    October 12, 2018
    Report Date
    February 12, 2019
    Manufacturer
    SANOFI / GENZYME. CORP
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS GIVEN SYNVISC ONE GEL SHOTS IN MY RIGHT KNEE, ONE PER WEEK FOR THREE WEEKS. AFTER EACH SHOT THE PAIN IN MY KNEE GOT PROGRESSIVELY WORSE. I WAS TOLD THAT IT SOMETIMES TOOK A FEW WEEKS FOR THE SHOT TO WORK. FOR 3 MONTHS I HAD THE WORST PAIN AND SWELLING I HAVE EVER HAD AND IT GOT WORSE EVEN THOUGH I WAS RESTING THE KNEE. IN ADDITION MY KNEE CAP BEGAN NOT TO TRACK CORRECTLY CAUSING EXCRUCIATING PAIN. I WAS THEN TOLD BY ANOTHER DOCTOR THAT A SMALL % OF PATIENTS HAVE BAD REACTIONS AND THERE HAVE BEEN RECALLS ON THIS PRODUCT IN THE PAST . I HAVE HAD THIS KNEE PROBLEM FOR MANY YEARS AND IT ALWAYS HAS HEALED QUICKLY WITH A LITTLE REST. I AM CONVINCED THAT THE PAIN AND DISCOMFORT THAT I AM STILL EXPERIENCING IS A RESULT OF THE SHOTS. I AM NOW SCHEDULED TO HAVE PARTIAL KNEE REPLACEMENT SURGERY FOR THE KNEE BECAUSE I STILL CAN¿T WALK WITHOUT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127555 SYNVISC-ONE ACID, HYALURONIC, INTRARTICULAR MOZ SANOFI / GENZYME. CORP
    127556 SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SANOFI / GENZYME, CORP
    127557 SYNVISC-ONE ACID, HYALURONIC, INTRAARTICULAR MOZ SANOFI / GENZYME, CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability