BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2971941 · Received February 19, 2013

    Report

    Report Number
    2246315-2013-00028
    Event Type
    Other
    Date Received
    February 19, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ARTHRITIS. KNEE PAIN [ARTHRALGIA]. KNEE SWELLING [JOINT SWELLING]. JOINT EFFUSION. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH GONARTHROSIS OF LEFT KNEE (K AND L GRADE 1). THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR MENISCAL INJURY OF LEFT KNEE (WHICH WAS DIAGNOSED FROM MAGNETIC RESONANCE IMAGING (MRI) FINDINGS WITH MINK'S CLASSIFICATION GRADE 2) AND ONGOING PAIN. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH FIRST SYNVISC (HYLAN GF-20) INJECTION OF THE FIRST COURSE, 2 ML, INTO THE LEFT KNEE (ROUTE OF ADMINISTRATION NOT PROVIDED). ON (B)(6) 2013, THE PATIENT RECEIVED SECOND SYNVISC INJECTION. ON (B)(6) 2013, THE PATIENT RECEIVED THE THIRD SYNVISC INJECTION. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2013, THE PATIENT COMPLAINED OF KNEE PAIN, KNEE SWELLING AND WAS DIAGNOSED WITH ARTHRITIS. ON (B)(6) 2013, ARTHROCENTESIS WAS PERFORMED AND 45 ML OF JOINT FLUID WAS ASPIRATED. ON (B)(6) 2013, 40 ML OF JOINT FLUID WAS ASPIRATED AND THE EVENT OF KNEE PAIN SUBSIDED. THE SAME DAY, THE PATIENT WAS TREATED WITH 2.5 ML OF ARTZ AND 1.65 MG OF DECADRON FOR THE EVENTS OF KNEE PAIN, KNEE SWELLING AND JOINT EFFUSION. ON AN UNSPECIFIED DATE IN (B)(6) 2013, ARTHROCENTESIS WAS PERFORMED AND 30 ML OF JOINT FLUID WAS ASPIRATED. THE PATIENT HAD NOT YET RECOVERED FROM THE EVENT OF ARTHRITIS AND THE OUTCOME FOR THE EVENTS OF JOINT EFFUSION AND KNEE SWELLING WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE CELCOX (CELECOXIB) AND MUCOSTA (REBAMIPIDE). THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTER ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ARTHRITIS AS DEFINITE AND DID NOT PROVIDE A RELATIONSHIP WITH THE OTHER EVENTS OF KNEE PAIN, KNEE SWELLING AND JOINT EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72722 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention