BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 3191005 · Received June 24, 2013

    Report

    Report Number
    2246315-2013-00372
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADVERSE REACTION IN THE RIGHT KNEE [ADVERSE REACTION], RIGHT KNEE WAS ASPIRATED [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN'S ASSISTANT VIA A COMPANY REPRESENTATIVE REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE WITH SYNVISC-ONE. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F 20) INTO BOTH KNEES, ONCE (DOSAGE REGIMEN AND ROUTE OF ADMINISTRATION NOT PROVIDED). ON AN UNSPECIFIED DATE IN 2013, THE PATIENT DEVELOPED AN ADVERSE REACTION IN THE RIGHT KNEE ONLY. ON (B)(6) 2013, THE PATIENT WAS SEEN BACK IN THE OFFICE AND UNKNOWN AMOUNT OF JOINT FLUID FROM THE RIGHT KNEE WAS ASPIRATED. THE OUTCOME AND INTENSITY FOR THE EVENTS OF ADVERSE REACTION IN THE RIGHT KNEE AND RIGHT KNEE EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP OF SYNVISC-ONE WITH BOTH THE EVENTS. FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN'S ASSISTANT REGARDING PATIENT DEMOGRAPHICS, SYNVISC-ONE DETAILS AND EVENTS INFORMATION THAT UPGRADED THE CASE TO SERIOUS. THE PATIENT WAS IDENTIFIED WITH INITIALS (B)(6). THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOARTHRITIS (DURATION: 05 YEARS; GRADE: MODERATE WITH NO PRIOR EFFUSION, OSTEOPHYTES AND JOINT NARROWING), KNEE EFFUSION, PREVIOUS USE WITH SYNVISC, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AND STEROIDS. THE PATIENT RECEIVED SYNVISC-ONE IN RIGHT KNEE AND 20 ML OF JOINT FLUID WAS ASPIRATED FROM THE RIGHT KNEE. ON (B)(6) 2013, THE PATIENT EXPERIENCED AN ADVERSE REACTION IN THE RIGHT KNEE. ON (B)(6) 2013, THE PATIENT WAS TREATED WITH CORTISONE (CORT) INJECTION; FOR BOTH THE EVENTS. ON (B)(6) 2013, THE PATIENT RECOVERED FROM THE EVENT OF ADVERSE REACTION IN THE RIGHT KNEE. THE INTENSITY FOR THE EVENT OF ADVERSE REACTION IN THE RIGHT KNEE WAS MODERATE. THE REPORTING ASSISTANT ASSESSED THE RELATIONSHIP OF SYNVISC-ONE WITH THE EVENT OF ADVERSE REACTION IN THE RIGHT KNEE AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286186 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK T12041

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention