BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 3735915 · Received April 2, 2014

    Report

    Report Number
    2246315-2014-38965
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    April 15, 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 COMMENT DATED (B)(4) 2014: IN THIS CASE, THE CAUSAL ROLE OF SYNVISC ONE CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT OF RELAPSING SYNOVITIS, HOWEVER THE OTHER RELEVANT MEDICAL HISTORY OF THE PT MAY PLAY A CONTRIBUTORY AND CONFOUNDING ROLE IN THE OCCURRENCE OF THE EVENT. FURTHERMORE, THE LACK OF INFO REGARDING THE CONCOMITANT MEDICATIONS USED BY THE PT PRECLUDES THE COMPLETE CASE ASSESSMENT.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS REC'D ON (B)(6) 2014 FROM A PHYSICIAN. THIS CASE CONCERNS A FEMALE PT OF UNK AGE WHO EXPERIENCED RELAPSING SYNOVITIS AND UNDERWENT "REPEATED PUNCTIONS OF RIGHT KNEE (EFFUSION RIGHT KNEE)" AFTER RECEIVING TREATMENT WITH SYNVISC ONE INJECTION. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR RIGHT KNEE GONARTHROSIS GRADE 2 SINCE 2011 AND KNEE ARTHROSCOPY IN (B)(6) 2013. NO PAST DRUGS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2013, THE PT REC'D TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (DOSE, BATCH/LOT NUMBER AND EXPIRATION DATE UNK) INTO HER RIGHT KNEE, FOR GONARTHROSIS. ON (B)(6) 2013, 52 ML OF SYNOVIAL FLUID WAS ASPIRATED, FROM THE PT'S RIGHT KNEE AND THE PT WAS DIAGNOSED WITH RELAPSING SYNOVITIS. ON (B)(6) 2013, THE PT UNDERWENT "REPEATED PUNCTIONS OF RIGHT KNEE" IN WHICH 35 ML, 55 ML, 34 ML, 45 ML AND 58 ML OF SYNOVIAL FLUID WAS ASPIRATED RESPECTIVELY. IT WAS REPORTED THAT THE REPEATED ASPIRATION WERE PERFORMED ALONG WITH THE REPEATED ADMINISTRATION OF BETAMETHASONE (DIPROPHOS) AND ANTI-INFLAMMATORY/ANT RHEUMATIC PRODUCTS (NSAIDS). ON AN UNK DATE IN 2013, THE PT'S SYNOVIAL FLUID CULTURE WAS NEGATIVE . IT WAS ALSO REPORTED THAT ARTHROSCOPY AND KNEE ENDOPROSTHESIS WAS RECOMMENDED TO THE PT. IN THE OPINION OF PHYSICIAN, RELAPSING SYNOVITIS WAS RELATED TO SYNVISC ONE ADMINISTRATION AFTER ARTHROSCOPY. OUTCOME: UNK FOR BOTH EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: INTERVENTION REQUIRED FOR BOTH THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199740 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CON MEDS =UNK| PREV MEDS =UNK