BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 511387 · Received February 10, 2004

    Report

    Report Number
    2246315-2004-00018
    Event Type
    Injury
    Date Received
    February 10, 2004
    Date of Event
    November 20, 2003
    Report Date
    February 10, 2004
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT RECEIVED AN INJECTION OF THEIR THIRD SERIES OF SYNVISC TO THE LEFT KNEE IN 2003. THE PT RETURNED TO THE PHYSICIAN FIVE DAYS LATER BECAUSE PT "EXPERIENCED PAIN AND PRESSURE IN THE KNEE." THE PHYSICIAN PALPATED THE KNEE AND REVEALED "A MEDIAN POPLITEAL CYST" AND WAS UNABLE TO ASPIRATE FLUID FROM THE CYST. AT THE TIME OF THIS REPORT, THE PT HAS NOT YET RECOVERED. THE PT HAS A HISTORY OF A RIGHT KNEE BAKER'S CYST AND MODERATE TO SEVERE OSTEOARTHRITIS WITH X-RAY FINDINGS SIGNIFICANT FOR JOINT NARROWING AND OSTEOPHYTES THAT HAS BEEN TREATED WITH VIOXX (12.5MG DAILY, PO). THE PT RECEIVED AN INJECTION OF SYNVISC TO THE RIGHT KNEE IN 2003. THE NEXT DAY THE PT EXPERIENCED KNEE PAIN, KNEE SWELLING AND AN ENLARGED BAKER'S CYST WHICH BECAME PAINFUL AND TENSELY SWOLLEN. SIX DAYS LATER, THE RHEUMATOLOGIST TREATED WITH PT WITH INTRA-ARTICULAR METHYL PREDNISOLONE (40MG). AT THE TIME OF THIS REPORT, THE PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC HYLAN G-F 20 MOZ GENZYME CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention