BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2214085 · Received July 21, 2011

    Report

    Report Number
    2246315-2011-00182
    Event Type
    Other
    Date Received
    July 21, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 14, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    KNEE PAIN [ARTHRALGIA]. SEDIMENTATION RATE INCREASED [RED BLOOD CELL SEDIMENTATION RATE INCREASED]. C-REACTIVE PROTEIN INCREASED [C-REACTIVE PROTEIN INCREASED]. PLATELET COUNT INCREASED [PLATELET COUNT INCREASED]. KNEES RED [ERYTHEMA]. KNEES WARM [JOINT WARMTH]. JOINT EFFUSION [JOINT EFFUSION]. SWOLLEN KNEES [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2011, FROM A MEDICAL ASSISTANT ON BEHALF OF A PHYSICIAN ASSISTANT REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS TREATMENT WITH SYNVISC IN 2006. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED SYNVISC 2ML 1/WEEK INTO BOTH KNEES. ON (B)(6) 2011, THE PATIENT RECEIVED THE THIRD INJECTION OF SYNVISC INTO BOTH KNEES. THE LOT NUMBER OF SYNVISC USED TO TREAT THE PATIENT WAS NOT PROVIDED. ON (B)(6) 2011, THE PATIENT RETURNED TO THE OFFICE WITH BOTH KNEES SWOLLEN, RED, AND WARM. A KNEE ASPIRATION WAS PERFORMED, WITH 65CC OF FLUID REMOVED FROM THE LEFT KNEE AND 45CC REMOVED FROM THE RIGHT KNEE. ON (B)(6) 2011, ANOTHER 45CC OF FLUID WERE REMOVED FROM THE LEFT KNEE AND 25CC FROM THE RIGHT KNEE. THE SYNOVIAL FLUID WAS CLOUDY AND WAS SENT FOR CULTURE; AFTER THREE DAYS, THE GRAM STAIN WAS NEGATIVE. BLOOD WORK SHOWED THAT THE PATIENT'S SEDIMENTATION RATE, C-REACTIVE PROTEIN, AND PLATELET COUNT WERE ALL ELEVATED. THE PATIENT CONTINUED TO EXPERIENCE KNEE PAIN AND WAS GIVEN AN INJECTION OF CORTISONE, WHICH DID NOT HELP WITH THE PAIN. THE PATIENT STARTED MEDROL ON (B)(6) 2011. THE PATIENT'S OUTCOME FOR THE EVENT OF KNEE PAIN WAS NOT YET RECOVERED, AND THE OUTCOME FOR THE OTHER EVENTS WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS WAS NOT ASSESSED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS WAS NOT PROVIDED BY THE REPORTING PHYSICIAN ASSISTANT. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention