BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1760389 · Received July 2, 2010

    Report

    Report Number
    2246315-2010-00133
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 25, 2010
    Manufacturer
    GENZYME BIOSURGERY
    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

    RESTRICTION OF MOVEMENT [MOBILITY DECREASED]. HYPERTHERMIA OF LEFT KNEE JOINT [JOINT WARMTH]. MASSIVE EFFUSION OF LEFT KNEE JOINT [JOINT EFFUSION]. SWELLING OF LEFT KNEE JOINT [JOINT SWELLING]. PAIN OF LEFT KNEE JOINT [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 AND (B)(6) 2010 FROM A PHYSICIAN REGARDING A (B)(6) MALE PATIENT, (B)(6), WITH A RELEVANT MEDICAL HISTORY OF LEFT GONARTHROSIS AND 1 SYNVISC INJECTION 1 YEAR AGO. THE PATIENT RECEIVED THE FIRST INJECTION OF HIS MOST RECENT COURSE OF SYNVISC THERAPY INTO THE KNEE ON (B)(6) 2010, AFTER WHICH THE SYNVISC TREATMENT WAS PERMANENTLY DISCONTINUED. THE SYNVISC BATCH NUMBER AND LOT NUMBER WERE (B)(4) AND S0912, RESPECTIVELY. STARTING ON THE EVENING OF (B)(6) 2010, THE PATIENT EXPERIENCED SWELLING OF THE KNEE JOINT AND PAIN. ON (B)(6) 2010, THE PATIENT DEVELOPED EFFUSION AND HYPERTHERMIA OF THE LEFT KNEE JOINT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010, WHERE JOINT PUNCTURE WAS PERFORMED AND APPROXIMATELY 80ML OF FLUID WAS ASPIRATED. THE PATIENT REPORTED RESTRICTION OF MOVEMENT. THE PHYSICIAN ASSESSED THE EVENTS AS SEVERE IN INTENSITY 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 30-JUN-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. (B)(4). 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 UNK S0912

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R