BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1760483 · Received July 2, 2010

    Report

    Report Number
    2246315-2010-00131
    Date Received
    July 2, 2010
    Report Date
    June 22, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 OUT OF 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

    I HAD NO LUCK [DEVICE INEFFECTIVE]. KNEE REPLACEMENT [KNEE ARTHROPLASTY]. CASE DESCRIPTION: SPONTANEOUS EVENT RECEIVED ON 22-JUN-2010 FROM AN ELDERLY MALE PATIENT IN HIS EIGHTIES, (B)(6), WITH A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS, LEFT KNEE PAIN, AND A SERIES OF SYNVISC INJECTIONS IN THE LEFT KNEE IN (B)(6)-2003. THE PATIENT STATED THAT ON (B)(6)-2006, THE FIRST OF THREE SYNVISC INJECTIONS WAS ADMINISTERED INTO THE LEFT KNEE. THE SYNVISC SERIES WAS COMPLETED ON AN UNKNOWN DATE IN 2006. THE PATIENT REPORTED HAVING "NO LUCK" AFTER COMPLETING THE SYNVISC SERIES IN THE LEFT KNEE. ON AN UNKNOWN DATE THE PATIENT HAD KNEE REPLACEMENT (SIDE NOT SPECIFIED). AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENT. THE SYNVISC LOT NUMBER WAS NOT PROVIDED. NO FURTHER INFORMATION ANTICIPATED. (B)(4): 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other