BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G - F 20) INJECTION

    MDR report key: 2612743 · Received June 6, 2012

    Report

    Report Number
    2246315-2012-00163
    Event Type
    Other
    Date Received
    June 6, 2012
    Date of Event
    May 13, 2012
    Report Date
    May 25, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PSEUDOGOUT [CHONDROCALCINOSIS PYROPHOSPHATE], RED KNEE [ERYTHEMA], HOT KNEE [JOINT WARMTH], SWOLLEN KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)2012 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G - F 20) INJECTION AT A DOSE OF 2 ML, ONCE IN AN UNSPECIFIED LOCATION. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON(B)(6) 2012, THE PT EXPERIENCED RED, HOT AND SWOLLEN KNEE. ON THE SAME DAY JOINT FLUID WAS ASPIRATED AND SYNOVIAL FLUID ANALYSIS SHOWED CALCIUM PYROPHOSPHATE DIHYDRATE CRYSTALS (PSEUDOGOUT). ON AN UNSPECIFIED DATE, THE PT WAS TREATED WITH STEROID INJECTION. THE OUTCOME FOR RED KNEE, HOT KNEE, SWOLLEN KNEE AND PSEUDOGOUT WAS NOT YET RECOVERED. THE ACTION TAKEN WITH SYNVISC WAS PERMANENTLY DISCONTINUED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS AS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G - F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention