BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED

    MDR report key: 490070 · Received October 17, 2003

    Report

    Report Number
    9612392-2003-00007
    Event Type
    Injury
    Date Received
    October 17, 2003
    Report Date
    October 17, 2003
    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

    THIS REPORT WAS OBTAINED FROM A DOCTOR AT A POSTER SESSION OF CLINICAL RHEUMATOID ASSOCIATION. REPORTER WHO CONDUCTED TOTAL KNEE ARTHROPLASTY (TKA) TO THE PATIENT STATED THE FOLLOWING AT THE POSTER SESSION: IT IS SUGGESTED THAT A FREQUENT INTRA-ARTICULAR INJECTION OF SODIUM HYALORNATE MADE THE OSTEOARTHRITIS OF THE KNEE ADVANCED. THE UTILITY OF SODIUM HYALURONATE IS BEING WELL KNOWN THOUGH; IT SHOULD BE NECESSARY TO CONSIDER THAT SOME SIDE EFFECT, INVALIDITY, AND AGGRAVATION EXIST IN SODIUM HYALURONATE. IN 1997, A PATIENT EXPERIENCED A PAIN IN THEIR LEFT KNEE. THE PAIN APPEARED ON THEIR RIGHT KNEE, TOO. FROM 1999 TO 2002, THEY HAVE RECEIVED AN INJECTION OF SODIM HYALURONATE SOLUTION TO THEIR LEFT KNEE ONCE A WEEK, AND RECEIVED ITS INJECTION TO THEIR RIGHT KNEE ONLY 2 OR 3 TIMES DURING 3 YEARS. IN 2002, THE PAIN OF BOTH KNEES INTENSIFIED. THE PAIN OF LEFT KNEE WAS MORE PAINFUL. THREE MONTHS LATER, THE PATIENT WAS REFERRED TO DEPT. OF ORTHOPEDIC SURGERY. TWO MONTHS LATER, THE PATIENT WAS HOSPITALIZED FOR TKA OF BOTH KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED SODIUM HYALURONATE MOZ SEIKAGAKU CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention