BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1760376 · Received July 2, 2010

    Report

    Report Number
    2246315-2010-00132
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 25, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER S0912, EXPIRY DATE 05/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    EFFUSION LEFT KNEE JOINT (JOINT EFFUSION). CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN REGARDING A (B)(6), FEMALE, PATIENT, INITIALS (B)(6) AND PATIENT NUMBER (B)(4), WITH A RELEVANT MEDICAL HISTORY OF LEFT GONARTHROSIS AND SYNVISC TREATMENT IN 2004. THE PATIENT RECEIVED THE FIRST INJECTION OF HER MOST RECENT COURSE OF SYNVISC THERAPY INTO THE KNEE ON (B)(6) 2010. THE SYNVISC BATCH NUMBER AND LOT NUMBER WERE 002333 AND S0912, RESPECTIVELY. THE PATIENT RECEIVED THE LAST SYNVISC INJECTION INTO THE KNEE ON (B)(6) 2010, AFTER WHICH THE SYNVISC TREATMENT WAS PERMANENTLY DISCONTINUED. STARTING ON (B)(6) 2010, THE PATIENT EXPERIENCED EFFUSION OF THE LEFT KNEE JOINT. A 40ML OF SEROUS FLUID WAS ASPIRATED. LABORATORY ANALYSIS REVEALED: INCREASED CRP (C-REACTIVE PROTEIN), INCREASED ESR (ERYTHROCYTE SEDIMENTATION RATE), AND NORMAL LEUKOCYTE LEVEL. THE PATIENT WAS STARTED "NSAR" AND ANTIBIOTICS. BY (B)(6) 2010, THE PATIENT WAS A "LITTLE BETTER" BUT WAS ADMITTED TO THE HOSPITAL FOR 3 ARTHROSCOPIC PROCEDURES (LAVAGE). THE PATIENT WAS DISCHARGED FROM IN-PATIENT TREATMENT AT THE HOSPITAL ON (B)(6) 2010. THE PHYSICIAN ASSESSED THE INTENSITY OF THE EVENTS AS SEVERE AND PROBABLY RELATED TO SYNVISC. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PATIENT OUTCOME WAS NOT YET RECOVERED. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER S0912, EXPIRY DATE 05/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. SEE MANUFACTURER'S CONTROL NUMBERS: (B)(4) FOR OTHER ADVERSE EVENT(S) FROM THIS REPORTER. 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 S0912

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R