BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1593828 · Received February 2, 2010

    Report

    Report Number
    2246315-2010-00019
    Event Type
    Other
    Date Received
    February 2, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 26, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# P09014, WITH EXP DATE 10/2011 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    INCREASED INFLAMMATION (KNEE) [ARTHRITIS], INCREASED PAIN IN KNEE [ARTHRALGIA], LEFT KNEE SWOLLEN [JOINT SWELLING], KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM AN HCP REGARDING A (B)(6) FEMALE PT WITH A HISTORY OF GONARTHROSIS OF THE KNEE, INITIALS (B)(6), WHO EXPERIENCED NON-SPECIFIC GONARTHROSIS MANIFESTING AS INCREASED PAIN IN THE KNEE, SWOLLEN LEFT KNEE, INCREASED INFLAMMATION, AND A KNEE EFFUSION AFTER STARTING SYNVISC. ON (B)(6) 2010, AN ADVERSE EVENT REPORT WAS RECEIVED FROM THE HCP, REPORTING THE FOLLOWING INFO: THE PT HAS A HISTORY OF GONARTHROSIS. THE PT RECEIVED TWO INJECTIONS OF SYNVISC INTO HER KNEE (SPECIFIC KNEE NOT PROVIDED) ON (B)(6) 2010 RESPECTIVELY. ON (B)(6) 2010, THE DAY AFTER THE SECOND INJECTION, THE PT EXPERIENCED NON-SPECIFIC GONARTHROSIS MANIFESTING AS INCREASED PAIN AND SWOLLEN LEFT KNEE. THE PT WAS TAKEN TO AN EMERGENCY CLINIC AND HER KNEE WAS ASPIRATED. THERE WAS NO INFECTION BUT INCREASED INFLAMMATION WAS SEEN. THE PHYSICIAN REPORTED THAT HE HAD ADMINISTERED SYNVISC FOLLOWING THE STANDARD OPERATING PROCEDURES IN A STERILE ROOM. THE PT'S LEG WAS STRETCHED AND THE INJECTION WAS GIVEN LATERALLY. THE FIRST SYNVISC INJECTION WAS GIVEN ON (B)(6) 2010 ALONG WITH 1ML DEPO-MEDROL AND 5ML XYLOCAINE. THE SECOND INJECTION OF SYNVISC WAS GIVEN ON (B)(6) 2010 ALONG WITH 5ML XYLOCAINE. IN THE OPINION OF THE HCP, THE PT HAD NOT YET RECOVERED FROM ALL THE ADVERSE EVENTS AT THE TIME OF THIS REPORT. FOR MORE INFO REGARDING OTHER EVENTS REPORTED BY THIS REPORTER, PLEASE REFER TO MFR CONTROL NUMBER (B)(4). ON (B)(4) 2010, ADDITIONAL INFO WAS RECEIVED IN THE FORM OF QA RESULTS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# P09014, WITH EXP DATE 10/2011 WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. 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 P09014

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention