BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 3452501 · Received October 30, 2013

    Report

    Report Number
    2246315-2013-09597
    Event Type
    Injury
    Date Received
    October 30, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 24, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2013: THIS CASE CONCERNS A PATIENT WHOSE RIGHT KNEE WENT BLACK AND BLUE AND WHO COULD NOT MOVE AFTER RECEIVING TREATMENT WITH SYNVISC FOR OSTEOARTHRITIS. ALTHOUGH, THE ROLE OF DEVICE CANNOT BE RULED OUT BASED ON TEMPORAL AND ANATOMICAL PROXIMITY, HOWEVER ROLE OF UNDERLYING OSTEOARTHRITIS IN CAUSATION CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    THIS SERIOUS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(4) 2013 FROM A PATIENT. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHOSE RIGHT KNEE WAS BLACK AND BLUE (JOINT HEMATOMA), FELT LIKE CEMENT IN IT (JOINT CREPITATION), COULD NOT WALK, EXPERIENCED PAIN ON WALKING AND HAD NO RELIEF (SUB-THERAPEUTIC RESPONSE) AFTER RECEIVING TREATMENT WITH SYNVISC INJECTION. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR MEDICAL DEVICE IMPLANTATION WITH SYNVISC INJECTION (ADMINISTERED IN (B)(6) 2013) WHICH WAS FINE. NO CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE REPORTED. ON AN UNKNOWN DATE IN 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 2 ML EVERY WEEK (ROUTE OF ADMINISTRATION, BATCH/LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) INTO BOTH KNEES FOR OSTEOARTHRITIS. ON (B)(6) 2013, THERAPY WITH SYNVISC INJECTION WAS COMPLETED. ALTHOUGH THE PATIENT RECEIVED SYNVISC INJECTIONS INTO BOTH KNEES BUT THE RIGHT KNEE WAS WORSE. ON UNSPECIFIED DATES IN (B)(6) 2013, IT WAS PAINFUL FOR THE PATIENT TO WALK THAT SHE CRIED AND RIGHT KNEE WAS BLACK AND BLUE (JOINT HEMATOMA). THE PATIENT WAS TREATED WITH HYDROCODONE BITARTRATE/PARACETAMOL (VICODIN) FOR JOINT HEMATOMA AND "PAINFUL TO WALK" BUT HER PRIMARY CARE PHYSICIAN (PCP) ADVISED NOT TO TAKE IT TOO MUCH AS IT WAS A HABIT-FORMING DRUG. LATER, ON UNKNOWN DATES IN (B)(6) 2013, THE PATIENT FELT LIKE CEMENT IN HER RIGHT KNEE DUE TO WHICH SHE COULD NOT WALK. THE PATIENT STATED THAT HER ORTHO PHYSICIAN ADVISED HER TO EXERCISE BUT WHEN SHE TRIED, SHE WAS UNABLE TO PULL UP THE LEG. AT THE TIME OF REPORT, SHE HAD NO RELIEF (SUB-THERAPEUTIC RESPONSE) AFTER THE TREATMENT WITH SYNVISC. OUTCOME: NOT RECOVERED/ NOT RESOLVED FOR THE EVENTS OF RIGHT KNEE WAS BLACK AND BLUE, FELT LIKE CEMENT IN IT, COULD NOT WALK AND PAIN ON WALKING. UNKNOWN FOR THE EVENT OF NO RELIEF (SUB-THERAPEUTIC RESPONSE). A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: THE EVENT OF COULD NOT MOVE AND RIGHT KNEE BLACK AND BLUE WAS ASSESSED AS SERIOUS PER THE NEW IME LIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556553 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other CON MEDS = UNK| SYNVISC (PREV.) (DATE OF TX: (B)(6) 2013 - UNK)