BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTZ DISPO (SUPARTZ)

    MDR report key: 376856 · Received February 19, 2002

    Report

    Report Number
    9612392-2002-00002
    Event Type
    Injury
    Date Received
    February 19, 2002
    Date of Event
    October 30, 2001
    Report Date
    February 18, 2002
    Manufacturer
    SEIKAGAKU CORP.
    Product Code
    MOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTHRITIS: THE PATIENT HAS RECEIVED INTRAARTICULAR INJECTION FROM TIME TO TIME FOR DIAGNOSIS OF OSTEOARTHROSIS OF BOTH KNEES FROM 1994. IN 2001, THE PATIENT RECEIVED THE INJECTION (ARTZ DISPO + 1% XYLOCAINE) INTO THE RIGHT KNEE 1 TIME IN JANUARY, 2 TIMES IN FEBRUARY, 1 TIME IN JULY. 1 TIME IN SEPTEMBER AND 2 TIMES IN OCTOBER. AS PAIN OF THE RIGHT KNEE WAS AGGRAVATED LATER IN OCTOBER, THE PATIENT CAME TO THE HOSPITAL. SYNOVIAL FLUID PUNCTURE WAS CONDUCTED AND THE CLINICAL COURSE WAS OBSERVED, BUT THE SYMPTOM WAS NOT MITIGATED (THE SYNOVIAL FLUID WAS YELLOW TRANSPARENT, AND THE RESULT OF CULTURE WAS NEGATIVE [-]). NOV 2001, THE PATIENT WAS ADMITTED TO THE HOSPITAL. A HIGH INFLAMMATORY REACTION WAS OBSERVED FROM BLOOD TEST. ARTHROSCOPY LATER IN NOVEMBER, 2001 SHOWED SYNOVIAL MEMBRANE PROLIFERATION, AND SYNOVECTOMY WAS CONDUCTED. ALTHOUGH TREATMENT WAS CONTINUED THEREAFTER, CONTRACTURE OF THE RIGHT KNEE REMAINED. IN DEC 2001, THE PATIENT WAS DISCHARGED AND THE CLINICAL COURSE WAS OBSERVED THEREAFTER UNTIL THE INFLAMMATORY REACTION TURNED NEGATIVE. IN JAN 2002, THE PATIENT WAS READIMITTED TO THE HOSPITAL AND A WEEK LATER RIGHT TOTAL KNEE REPLACEMENT WAS CONDUCTED.

    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 82 YR Hospitalization 2001.| XYLOCAINE (LIDOCAINE HYDROCHLORIDE): 1994 TO