BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2379101 · Received December 13, 2011

    Report

    Report Number
    2246315-2011-00312
    Event Type
    Other
    Date Received
    December 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    December 7, 2011
    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

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    ONE KNEE PRACTICALLY FROZE [JOINT LOCK]. PAIN WITH WALKING LONG DISTANCES [PAIN]. PAIN IN THE SOFT TISSUE AROUND THE KNEE (KNEE PAINFUL) [ARTHRALGIA]. SWELLING IN RIGHT KNEE [JOINT SWELLING]. RIGHT KNEE EFFUSION [JOINT EFFUSION]. MY CONDITION HAS WORSENED [DEVICE INEFFECTIVE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A (B)(6) MALE PT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2011, THE PT INITIATED TREATMENT WITH SYNVISC-ONE (HYLAN G-F 20) 6 ML, ONCE IN BOTH THE KNEES. THE LOT NUMBER WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2011, THE PT'S CONDITION WORSENED. THE PT STATED THAT ONE OF HIS KNEES PRACTICALLY FROZE AND WAS VERY PAINFUL. THE PT EXPERIENCED SWELLING IN HIS RIGHT KNEE AND ALSO EXPERIENCED PAIN WHILE WALKING LONG DISTANCES. IN ADDITION TO THIS, THERE WAS PAIN IN THE SOFT TISSUES AROUND THE KNEE. ON (B)(6) 2011, THE PT WAS SEEN BY HIS HEALTH CARE PROFESSIONAL AND AN UNK AMOUNT OF FLUID WAS REMOVED FROM HIS RIGHT KNEE. HE WAS INJECTED WITH A CORTISONE INJECTION THE SAME DAY. OTHER TREATMENT MEDICATION INCLUDED ASPIRIN (ACETYLSALICYLIC ACID). NO ACTION WAS TAKEN WITH SYNVISC-ONE. THE PT'S OUTCOME FOR ALL THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention