BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2589978 · Received May 23, 2012

    Report

    Report Number
    2246315-2012-00146
    Event Type
    Injury
    Date Received
    May 23, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 21, 2012
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ARTHRITIS OF LEFT KNEE [ARTHRITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH GONARTHROSIS. THE PT¿S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOPOROSIS, HYPERTENSION, HYPERCHOLESTEROLAEMIA AND OVERACTIVE BLADDER. ON (B)(6) 2012, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION AT A DOSE OF 2 ML PER WEEK (LEFT JOINT). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. THE PT RECEIVED SECOND AND THIRD INJECTION OF SYNVISC ON (B)(6) 2012, RESPECTIVELY. ON (B)(6) 2012, THE PT EXPERIENCED ARTHRITIS OF LEFT KNEE. ON (B)(6) 2012, HER SYNOVIAL FLUID ANALYSIS WAS PERFORMED WHICH REVEALED THAT FLUID BACTERIUM CULTURE WAS NEGATIVE, CPPD IN FLUID WAS NEGATIVE, CRP WAS 2.32 AND WBC WAS 8000. ON (B)(6) 2012, THE PT WAS HOSPITALIZED. ON (B)(6) 2012, THE EVENT OF ARTHRITIS OF LEFT KNEE ALLEVIATED. IT WAS REPORTED THAT SHE HAD STILL BEEN HOSPITALIZED AND ON (B)(6) 2012, HER SYNOVIAL FLUID ANALYSIS REVEALED CRP (1.25) AND WBC (7400). THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF ARTHRITIS OF LEFT KNEE WAS NOT YET RECOVERED. RELEVANT CONCOMITANT MEDICATIONS INCLUDED TELMISARTAN, ATORVASTATIN CALCIUM HYDRATE, CELECOXIB, ALFACALCIDOL, SOLIFENACIN SUCCINATE AND ALENDRONATE SODIUM HYDRATE. THE INTENSITY FOR THE EVENT OF ARTHRITIS OF LEFT KNEE WAS NOT PROVIDED. THE REPORTER ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ARTHRITIS OF LEFT KNEE 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 CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization