BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO (= SUPARTZ)

    MDR report key: 472520 · Received July 18, 2003

    Report

    Report Number
    9612392-2003-00006
    Event Type
    Injury
    Date Received
    July 18, 2003
    Date of Event
    April 4, 2003
    Report Date
    July 18, 2003
    Manufacturer
    SEIKAGAKU CORP
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED THE INITIAL INJECTION OF ARTZ DISPO TO THEIR KNEE JOINT AFTER DRAINAGE OF JOINT FLUID DUE TO OA OF THEIR LEFT KNEE. 6 DAYS LATER, THE 2ND INJECTION WAS GIVEN AFTER DRAINAGE OF 23ML OF TRANSPARENT JOINT FLUID. 7 MONTHS LATER, THEY RECEIVED THE 26TH INJECTION TO THEIR KNEE JOINT. IN THE SAME DAY, THEIR KNEE JOINT SWELLED TWO-FOLD SIZE, AND WENT TO AN EMERGENCY HOSP. ACCORDING TO A REPORT FROM THE HOSP, THEY DRAINED ABOUT 70ML OF TURBID FLUID DUE TO THE SWELLING THE NEXT DAY. FROM THE DRAINED FLUID, STERPTOCOCUS WAS POSITIVE. 12 DAYS LATER, CPR VALUE SHOWED 16.2. 6 DAYS LATER THEY WERE ADMITTED TO ANOTHER HOSP. 5 DAYS LATER, A SYNOVECTOMY WAS PERFORMED UNDER AN ARTHROSCOPE. UNDER THE ARTHROSCOPE, SINCE A PROLIFERATED LIPID WAS CLEARLY OBSERVED, THE PART WAS CUT OFF BY A SHAVER AND DRAINED AS QUICKLY AS POSSIBLE. AS OF ONE MONTH LATER, THE CPR SHOWED HIGHER VALUE BETWEEN 0.5 AND 0.8, WHICH IS A LITTLE HIGHER THAN THE NORMAL VALUE, BUT THE PT IS KEEPING AN EVENT CONDITION FROM A CLINICAL POINT OF VIEW. AT THE PRESENT THEY IMPROVED AND IS ATTENDING THE HOSP WHERE THEY RECEIVED INJECTIONS OF ARTZ DISPO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTZ DISPO (= SUPARTZ) SODIUM HYALURONATE MOZ SEIKAGAKU CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization