BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1853197 · Received September 28, 2010

    Report

    Report Number
    2246315-2010-00197
    Event Type
    Other
    Date Received
    September 28, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 16, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DIFFICULTY WALKING [GAIT DISTURBANCE]. RIGHT KNEE REDNESS [ERYTHEMA]. RIGHT KNEE EFFUSION [JOINT EFFUSION]. RIGHT KNEE SWELLING [JOINT SWELLING]. RIGHT KNEE PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN VIA AN X-RAY TECHNICIAN, REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS. THE PATIENT RECEIVED THE FIRST INJECTION OF SYNVISC INTO THE RIGHT KNEE ON (B)(6) 2010. THE SYNVISC LOT NUMBER WAS S1009 WITH EXPIRATION DATE MAY-2013. THE DAY AFTER RECEIVING THE SYNVISC INJECTION, THE PATIENT EXPERIENCED RIGHT KNEE PAIN, SWELLING, REDNESS, AND DIFFICULTY WALKING. ON (B)(6) 2010, THE RIGHT KNEE WAS ASPIRATED OF 52 CC'S OF BLOOD TINGED, YELLOWISH FLUID AND INJECTED WITH LIDOCAINE AND CELESTONE. THE PATIENT DID NOT RECEIVE THE LAST TWO SYNVISC INJECTIONS. ADDITIONAL TREATMENT FOR THE EVENTS INCLUDED: REST AND ICE. THE PHYSICIAN ASSESSED THE RELATION OF THE EVENTS WITH SYNVISC AS PROBABLE. NO FURTHER INFORMATION WAS PROVIDED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER S1009, EXPIRY DATE 05/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'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 S1009

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention