BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3168262 · Received June 11, 2013

    Report

    Report Number
    2246315-2013-00349
    Event Type
    Other
    Date Received
    June 11, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    TIGHTNESS IN BOTH KNEES [JOINT STIFFNESS]. EFFUSION IN BOTH KNEES [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN'S ASSISTANT REGARDING A (B)(6) MALE PATIENT, INITIALS (B)(6). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, INTO AN UNSPECIFIED KNEE, ROUTE AND DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON UNSPECIFIED DATES, THE PATIENT DEVELOPED TIGHTNESS IN BOTH KNEES AND PAIN IN BOTH KNEES. ON AN UNSPECIFIED DATE, 70 CC OF FLUID WAS ASPIRATED FROM BOTH KNEES. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. ON UNSPECIFIED DATES, THE PATIENT RECOVERED FROM TIGHTNESS IN BOTH KNEES AND PAIN IN BOTH KNEES. THE OUTCOME FOR THE EVENT OF EFFUSION IN BOTH KNEES WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS WAS NOT PROVIDED. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN'S ASSISTANT REGARDING THE PATIENT'S MEDICAL HISTORY, PRODUCT INFORMATION, LOT NUMBER, EVENTS INFORMATION AND PATIENT'S CLINICAL COURSE AND TREATMENT MEDICATION WHICH UPGRADED THE CASE TO SERIOUS. THE EVENT OF PAIN IN BOTH KNEES WAS DELETED AS IT WAS NOT CONSIDERED AS A SEPARATE ADVERSE EVENT. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR MODERATE OSTEOARTHRITIS OF BOTH KNEES SINCE FOUR YEARS WITH JOINT NARROWING, PREVIOUS TREATMENT WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS AND STEROIDS. ON (B)(6) 2013, THE PATIENT RECEIVED THE FIRST INTRA-ARTICULAR SYNVISC INJECTION AT A DOSAGE OF 2 ML ONCE PER WEEK INTO BOTH KNEES. ON (B)(6) 2013, THE PATIENT RECEIVED SECOND SYNVISC INJECTION. ON (B)(6) 2013, THE PATIENT RECEIVED THIRD SYNVISC INJECTION. ON (B)(6) 2013, THE PATIENT DEVELOPED TIGHTNESS IN BOTH KNEES AND EFFUSION IN BOTH KNEES. ON (B)(6) 2013, 70+ ML OF SYNOVIAL FLUID WAS ASPIRATED FROM THE KNEES. THE SAME DAY, THE PATIENT WAS INJECTED WITH 1 ML DEPO-MEDROL (METHYL PREDNISOLONE SUCCINATE) AND 1 ML LIDOCAINE (2%) INTO BOTH KNEES. ON UNSPECIFIED DATE, THE PATIENT RECOVERED FROM EFFUSION IN BOTH KNEES. THE INTENSITY FOR THE EVENTS OF TIGHTNESS IN BOTH KNEES AND EFFUSION IN BOTH KNEES WAS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC WITH THE EVENTS OF TIGHTNESS IN BOTH KNEES AND EFFUSION IN BOTH KNEES AS DEFINITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264829 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK R12143

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention