BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3232257 · Received July 12, 2013

    Report

    Report Number
    2246315-2013-00397
    Event Type
    Other
    Date Received
    July 12, 2013
    Date of Event
    January 1, 2013
    Report Date
    July 3, 2013
    Manufacturer
    GENZYME BIOSURGERY
    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 SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    SWELLING OF KNEE [JOINT SWELLING]. PAIN IN RIGHT KNEE [ARTHRALGIA]. JOINT EFFUSION [JOINT EFFUSION]. PYREXIA. HOT FEELING OF KNEE [JOINT WARMTH]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) MALE PATIENT, INITIALS (B)(6), WITH GONARTHROSIS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT INITIATED THE TREATMENT WITH FIRST SYNVISC (HYLAN G-F 20) INJECTION AT A DOSE OF 02 ML (FREQUENCY AND ROUTE OF ADMINISTRATION NOT PROVIDED) INTO AN UNSPECIFIED KNEE. ON (B)(6) 2013, THE PATIENT RECEIVED SECOND SYNVISC INJECTION. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PAIN IN RIGHT KNEE. THE PATIENT ALSO DEVELOPED JOINT EFFUSION. ON (B)(6) 2013, SWELLING OF THE KNEE DEVELOPED WITH HOT FEELING OF KNEE. THE SAME DAY, ARTHROCENTESIS WAS PERFORMED BY PHYSICIAN IN WHICH 25 ML OF CLOUDY FLUID WAS ASPIRATED AND WAS SUBMITTED FOR BACTERIAL CULTURE. IN CONSIDERATION OF POSSIBLE INFECTION, JOINT LAVAGE WAS CONDUCTED WITH 1000 ML OF LIQUID (UNSPECIFIED). AT 20:00, HE HAD PYREXIA OF 38.4 DEGREES CELSIUS. THE PATIENT WAS TREATED WITH MODACIN (CEFTAZIDIME) INFUSION AT A DOES OF 02 G FOR ALL THE EVENTS. THE TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. AT THE TIME OF REPORT, THE PATIENT HAD NOT YET RECOVERED FROM THE EVENT OF SWELLING OF KNEE. THE OUTCOME OF THE EVENTS OF PAIN IN RIGHT KNEE, HOT FEELING OF KNEE, JOINT EFFUSION AND PYREXIA WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY OF ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SWELLING OF KNEE AS POSSIBLE AND DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF HOT FEELING OF KNEE, PAIN IN RIGHT KNEE, JOINT EFFUSION AND PYREXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321822 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention