BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1821707 · Received August 27, 2010

    Report

    Report Number
    2246315-2010-00165
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 17, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STIFFNESS [JOINT STIFFNESS]. EXCRUCIATING PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PT VIA A COMPANY REP AND ON (B)(6) 2010 FROM THE PT WHO WAS A (B)(6) MALE, INITIALS (B)(6), WITH A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS OF THE HIPS AND 3 PREVIOUS SYNVISC INJECTIONS INTO THE RIGHT AND LEFT HIPS IN (B)(6) 2009 WITH GOOD RESULTS (PAIN FREE). THE PT RECEIVED THE FIRST INJECTION OF THE MOST RECENT SERIES OF SYNVISC INJECTIONS INTO THE RIGHT HIP ON (B)(6) 2010. THE SYNVISC LOT NUMBER WAS N1004A, WITH EXPIRATION DATE JAN-2013. AFTER RECEIVING THE FIRST INJECTION, THE PT EXPERIENCED EXCRUCIATING PAIN FOR 3 DAYS ALONG WITH STIFFNESS. THE PAIN SUBSIDED AFTER 5 DAYS. THE SECOND SYNVISC INJECTION WAS RECEIVED IN THE LEFT HIP ON (B)(6) 2010. AFTER RECEIVING THE SECOND INJECTION, THE PT AGAIN EXPERIENCED EXCRUCIATING PAIN AND WENT TO THE HOSPITAL ER (EMERGENCY ROOM) WHERE THE ANTI-INFLAMMATORY DRUGS DEMEROL AND DILAUDID WERE ADMINISTERED. A PRESCRIPTION FOR DILAUDID WAS ALSO PRESCRIBED. THE PT THEN WENT FOR AN ULTRASOUND TO RULE OUT INFECTION, AND THERE WAS NO INFECTION. THE PT WAS IN PAIN FROM (B)(6) 2010. THE PT HAD GONE TO SEE THE FAMILY DOCTOR ON (B)(6) 2010. ON (B)(6) 2010 THE PAIN SUBSIDED. THE PT WAS ABLE TO FUNCTION AND FEEL "OKAY," WITH CONTINUED TREATMENT ON HYDROMORPH CONTIN, OXYCOCET AND DILAUDID. THE OUTCOME OF STIFFNESS WAS NOT PROVIDED. THE PT USED ONLY 2 OF THE 3 SYNVISC INJECTIONS. CONCOMITANT MEDICATIONS REPORTED INCLUDED: LIDOCAINE AND DYE. MFR'S COMMENT: THE BENEFIT RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK N1004A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LIDOCAINE (LIDOCAINE HYDROCHLORIDE)| DYE