BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN GF-20) INJECTION

    MDR report key: 1912783 · Received November 2, 2010

    Report

    Report Number
    2246315-2010-00221
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 25, 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

    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

    EXTREME STIFFNESS OF LEFT KNEE [JOINT STIFFNESS]. UNABLE TO WEIGHT BEAR [WEIGHT BEARING DIFFICULTY]. SEVERE PAIN OF LEFT KNEE [ARTHRALGIA]. SWELLING OF LEFT KNEE, TRIPLED IN SIZE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A (B)(6) YEAR-OLD FEMALE PATIENT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF OSTEOARTHRITIS AND PREVIOUS TREATMENT WITH SYNVISC THREE TO FOUR TIMES IN THE PAST. THE PATIENT WAS ADMINISTERED SYNVISC-ONE ON (B)(6) 2010 IN THE LEFT KNEE. WITHIN EIGHT HOURS OF RECEIVING THE SYNVISC-ONE INJECTION, THE PATIENT EXPERIENCED EXTREME STIFFNESS, SEVERE PAIN, AND SWELLING OF HER LEFT KNEE WHICH THE PATIENT STATED TRIPLED IN SIZE. THE PATIENT WAS ALSO UNABLE TO BEAR WEIGHT FOR FIVE DAYS. THE SYMPTOMS STARTED TO IMPROVE AFTER SEVEN DAYS. TREATMENTS INCLUDED VICODIN (ACETAMINOPHEN/ HYDROCODONE), ORAL STEROIDS, NAPROSYN (NAPROXEN), AND CRUTCHES. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE REPORTED EVENTS WAS NOT YET RECOVERED. THE SYNVISC-ONE LOT NUMBER WAS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention