BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 3735883 · Received April 2, 2014

    Report

    Report Number
    2246315-2014-38445
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    July 9, 2013
    Report Date
    March 26, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6)-2014: THIS CASE CONCERNS A PT WHO EXPERIENCED TEMPORAL WORSENING OF GONARTHROSIS AFTER RECEIVING SYNVISC ONE FOR BILATERAL GONARTHROSIS. ALTHOUGH THE ROLE OF DEVICE CANNOT BE RULED OUT BASED ON THE DEVICE EVENT TEMPORAL RELATIONSHIP; HOWEVER, LACK OF DETAILED INFO ABOUT MEDICAL HISTORY, LAB DATA, ANY CONCURRENT MEDICAL ILLNESSES, CLINICAL COURSE ETC. OF THE PT PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE WAS REC'D FROM (B)(6) ON (B)(6)-2014 FROM A PHYSICIAN. THIS CASE WAS CROSS REFERENCED TO CASE (B)(4) (CLUSTER). THIS CASE CONCERNS AN ELDERLY FEMALE PT (AGE NOT PROVIDED) WHO COMPLAINED OF TEMPORAL WORSENING OF GONARTHROSIS AFTER RECEIVING SYNVISC-ONE INJECTION. MEDICAL HISTORY INCLUDED PREVIOUS USE OF CURAVISC (HYALURONIC ACID). NO CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS REPORTED. ON (B)(6)-2013, THE PT REC'D TREATMENT WITH INTRA-ARTICULAR SYNVISC-ONE INJECTION, ONCE (DOSE, BATCH/LOT AND EXPIRATION DATE NOT REPORTED) IN RIGHT KNEE FOR BILATERAL GONARTHROSIS (GRADE 2). ON (B)(6)-2013, 126 DAYS AFTER THE SYNVISC-ONE INJECTION, THE PT COMPLAINED OF TEMPORAL WORSENING OF GONARTHROSIS. IT WAS REPORTED THAT NO KNEE JOINT EXUDATE OCCURRED. ON (B)(6)-2013, THE PT PRESENTED IMPROVEMENT IN THIS STATUS. ON (B)(6)-2013, BOTH KNEES WERE CALM W/O ANY EVENT AND THE PT RECOVERED. IN REPORTING PHYSICIAN'S OPINION IT WAS NOT TYPICAL COMPLICATION AFTER SYNVISC ONE ADMINISTRATION, IN GENERAL IT SEEMS TO BE IMPROVEMENT IN PT STATUS. CORRECTIVE TREATMENT: BETAMETHASONE DIPROPIONATE/BETAMETHASONE SODIUM PHOSPHATE (DIPROFOS). OUTCOME: RECOVERED/ RESOLVED. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION (REC'D TREATMENT WITH STEROID). A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). NO F/U WOULD BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199695 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HYALURONIC ACID (PREV.)| CON MEDS =UNK