BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2831188 · Received November 6, 2012

    Report

    Report Number
    2246315-2012-00342
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 1, 2012
    Manufacturer
    GENZYME BIOSURGEY RIDGEFIELD
    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 [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 HYPOTHYROIDISM, DYSLIPIDEMIA AND PREVIOUS USE OF ARTZ INJECTIONS. ON (B)(6) 2012, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, ROUTE AND DOSAGE REGIMEN NOT PROVIDED, IN THE RIGHT KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PT RECEIVED SECOND SYNVISC INJECTION. ON (B)(6) 2012, THE PT DEVELOPED ARTHRITIS. ON THE SAME DAY, THE PT HAD A JOINT FLUID TEST AND WAS ADMITTED TO THE HOSPITAL. ALSO, THE PT UNDERWENT ARTHROSCOPIC INTRA-ARTICULAR LAVAGE. THE EVENT OF ARTHRITIS WAS NOT YET RECOVERED. CONCOMITANT MEDICATIONS INCLUDED LEVOTHYROXINE SODIUM HYDRATE, ROSUVASTATIN CALCIUM AND FAMOTIDINE. THE INTENSITY FOR THE EVENT OF ARTHRITIS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ARTHRITIS 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 BIOSURGEY RIDGEFIELD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R