BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 3893842 · Received June 12, 2014

    Report

    Report Number
    2246315-2014-75094
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    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

    PHARMACOVIGILANCE COMMENT: SANOFI INITIAL COMPANY COMMENT DATED (B)(4) 2014: THIS CASE CONCERNS A MALE PT WHO EXPERIENCED BILATERAL GONARTHRITIS WHILE RECEIVING TREATMENT WITH SYNVISC FOR GONARTHRITIS. IN THIS CASE, THE CAUSAL ROLE OF SYNVISC CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT, HOWEVER, THE LACK OF INFO REGARDING THE UNDERLYING MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS USED BY THE PT PRECLUDES THE COMPLETE CASE ASSESSMENT.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6) 2014 FROM THE INTERNIST. THIS CASE CONCERNS A (B)(6) YEAR OLD MALE PT WAS CONCURRENT CONDITIONS WERE REPORTED. PAST DRUGS INCLUDED STEROIDS UNSPECIFIED AND HYALURONATE SODIUM (ARTZ) FOR 2 YEARS. ON (B)(6) 2014, THE PT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION, AT A DOSE OF 2 ML(FREQUENCY, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) FOR GONARTHROSIS. ON (B)(6) 2014, THE PT RECEIVED THE SECOND DOSE OF SYNVISC INJECTION AT A DOSE OF 2 ML. SUBSEQUENTLY, (14 DAYS AFTER STARTING TREATMENT WITH SYNVISC), THE PT COMPLAINED OF PAIN IN BOTH KNEES AND PT DEVELOPED BILATERAL GONARTHRITIS. THE SAME DAY, TREATMENT WITH SYNVISC WAS DISCONTINUED. ARTHROCENTESIS WAS PERFORMED AND 25 ML OF FLUID WAS ASPIRATED FROM RIGHT KNEE AND 10 ML OF FLUID WAS ASPIRATED FROM LEFT KNEE. THE C-REACTIVE PROTEIN LEVEL WAS 3.9 MG/DL. ALSO, REPORTED THAT THE BACTERIAL GONARTHRITIS WAS RULED OUT. THE PT INITIATED TREATMENT WITH STEROIDS (UNSPECIFIED) AND ANTIBIOTICS (UNSPECIFIED) FOR THE EVENT OF BILATERAL GONARTHRITIS. OUTCOME: NOT YET RECEIVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4) AND CONCLUSION WAS PENDING FOR THE SAME. BILATERAL GONARTHRITIS. SERIOUS ASSESSMENT: BILATERAL GONARTHRITIS: SERIOUS (REQUIRED INTERVENTION). REPORTING INTERNIST'S CAUSALITY ASSESSMENT: PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348637 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention CORTICOSTEROID NOS (PREV.) UNK| CON MEDS = UNK| ARTZ (PREV.) UNK