BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2259058 · Received September 16, 2011

    Report

    Report Number
    2246315-2011-00222
    Event Type
    Other
    Date Received
    September 16, 2011
    Date of Event
    August 14, 2011
    Report Date
    September 9, 2011
    Manufacturer
    GENZYME BIOSURGERY (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 THE REPORT.

    Description of Event or Problem · 1

    PAIN IN RIGHT KNEE [ARTHRALGIA]. SWELLING OF RIGHT KNEE [JOINT SWELLING]. JOINT EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2011 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH GONARTHROSIS. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR OSTEOPOROSIS. ON (B)(6)-2011, THE PT INITIATED THE SYNVISC INJECTION OF 2 ML INTO THE RIGHT KNEE. THE SYNVISC LOT NUMBER WAS NOT PROVIDED. ON (B)(6)-2011, THE PT INITIATED THE SECOND INJECTION OF 2 ML INTO THE RIGHT KNEE. ON (B)(6)-2011, THE PT EXPERIENCED PAIN IN RIGHT KNEE, SWELLING IN RIGHT KNEE AND RIGHT KNEE EFFUSION. ON THE SAME DAY, THE PT VISITED ANOTHER INSTITUTE TO HAVE JOINT FLUID ASPIRATED. LAB TESTS WERE PERFORMED. THE RESULTS OF ARTHROSCOPE AND SYNOVIAL FLUID BACTERIUM CULTURE RULED OUT GOUT, PSEUDOGOUT AND INFECTION. ON (B)(6)-2011, SYNVISC WAS PERMANENTLY DISCONTINUED. THE PT'S OUTCOME FOR THE EVENT OF "PAIN IN RIGHT KNEE, SWELLING IN RIGHT KNEE AND RIGHT KNEE EFFUSION" WAS REPORTED AS NOT YET RECOVERED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE: 35 MG OF ALENDRONATE SODIUM HYDRATE 1/1 WEEK, FOR OSTEOPOROSIS AND IS STILL CONTINUING. THE INTENSITY FOR THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF "PAIN IN RIGHT KNEE, SWELLING IN RIGHT KNEE AND RIGHT KNEE EFFUSION" AS DEFINITELY RELATED.

    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 76 YR Required Intervention