BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1202787 · Received October 16, 2008

    Report

    Report Number
    2246315-2008-00150
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    GENZYME BIOSURY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    SWELLING IN LEFT KNEE [JOINT SWELLING]. LEFT KNEE PAIN [ARTHRALGIA]. ABNORMAL SYNOVIAL FLUID GLUCOSE [SYNOVIAL FLUID GLUCOSE PRESENT]. HIGH SYNOVIAL FLUID WHITE BLOOD CELL COUNT [SYNOVIAL FLUID WHITE BLOOD CELLS POSITIVE]. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 22-SEP-2008 FROM A PHYSICIAN REGARDING A (B) (6) FEMALE PT, (B) (6), WHO HAD AN UNK RELEVANT MEDICAL HISTORY. THE PT RECEIVED HER FIRST SYNVISC INJECTION IN HER LEFT KNEE IN (B) (6) 2008. ON (B) (6) 2008, SHE RECEIVED HER SECOND SYNVISC INJECTION IN HER LEFT KNEE. SEVERAL HOURS AFTER THE SECOND INJECTION ON (B) (6) 2008, THE PT EXPERIENCED LEFT KNEE SWELLING AND PAIN. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS UNK. NO FURTHER INFO WAS AVAILABLE. ADDITIONAL INFO WAS RECEIVED ON 03-OCT-2008 FROM THE TREATING PHYSICIAN. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS UPDATED TO INCLUDE: MILD GRADE OF OA (OSTEOARTHRITIS) IN THE LEFT KNEE BASED ON X-RAY EXAMINATION; OA DURATION OF "YEARS"; NO PREVIOUS OA ASSOCIATED FINDINGS OF EFFUSION, JOINT NARROWING OR OSTEOPHYTES; FINDINGS OF PREVIOUS TREATMENT WITH NSAIDS, AND ONE PRIOR COURSE OF SYNVISC THERAPY. THE PT RECEIVED HER FIRST SYNVISC INJECTION TO HER LEFT KNEE ON (B) (6) 2008 WITH NO EFFUSION COLLECTED BEFORE THE INJECTION. THE PT RECEIVED HER SECOND SYNVISC INJECTION TO HER LEFT KNEE ON (B) (6) 2008 WITH NO EFFUSION COLLECTED BEFORE THE INJECTION. SEVERAL HOURS AFTER THE SECOND INJECTION ON (B) (6) 2008, THE PT EXPERIENCED LEFT KNEE SWELLING AND LEFT KNEE PAIN. ON (B) (6) 2008, THE PHYSICIAN COLLECTED 50 ML OF EXUDATE FROM THE PATIENT'S LEFT KNEE. SYNOVIAL FLUID ANALYSIS REVEALED A CLOUDY AND YELLOW FLUID WITH THE FOLLOWING ABNORMALITIES: ELEVATED SYNOVIAL WBCS AT 32.0 X 10E3/L (NORMAL RANGE 0.0-0.2 X 10E3/L) WITH 63% NEUTROPHILS, 13% LYMPHOCYTES, 11% EOSINOPHILS, 9% MONOCYTES AND 4% MESOTHELIAL CELLS; PRESENCE OF GLUCOSE AT <0.5 MMOL/L. THERE WERE NO CRYSTALS PRESENT AND FEW RBCS WERE NOTED (0.4 X 10E12/L). ON (B) (6) 2008, THE PATIENT'S LEFT KNEE PAIN AND SWELLING WAS TREATED WITH A 1CC INJECTION OF 80 MG/ML DEPO-MEDROL. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT'S OUTCOME IS UNK. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention