BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2792433 · Received October 8, 2012

    Report

    Report Number
    2246315-2012-00309
    Event Type
    Other
    Date Received
    October 8, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    RIGHT KNEE PAIN [ARTHRALGIA]. RIGHT KNEE SWOLLEN/RIGHT KNEE IS A "BIG GRAPE FRUIT" [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. CANNOT PUT ANY WEIGHT ON KNEE [WEIGHT BEARING DIFFICULTY]. COULD NOT LIFT HIS FOOT [JOINT RANGE OF MOTION DECREASED]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 (ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012) FROM AN (B)(6), WITH OSTEOARTHRITIS OF RIGHT KNEE. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS TREATMENT WITH THREE CORTISONE SHOTS. ON AN UNSPECIFIED DATE IN (B)(6) 2012 (5 WEEKS AGO), THE PATIENT RECEIVED SYNVISC ONE (HYLAN G-F 20) INJECTION AT A DOSE OF 6 ML, ONCE (ROUTE NOT PROVIDED). THE LOT NUMBER OF SYNVISC ONE WAS NOT PROVIDED. ON (B)(6) 2012 AT 3 AM, THE PATIENT EXPERIENCED A LOT OF PAIN AND SWELLING IN HIS RIGHT KNEE (RIGHT KNEE WAS A BIG GRAPEFRUIT). SINCE THEN, THE PATIENT WAS GOING TO THE BATHROOM EVERY HALF AN HOUR. THE PATIENT REPORTED THAT IT COULD BE BECAUSE HE WAS EATING DIFFERENTLY THAN BEFORE OR A RESULT OF HIS ACTIVITY LEVEL. IT WAS REPORTED THAT THE PATIENT WAS WORKING OUT AND HAD PHYSICAL THERAPY ON (B)(6) 2012. THE PATIENT WAS NOT ABLE TO PUT ANY WEIGHT ON HIS KNEE AND COULD NOT LIFT HIS FOOT AND STAYED IN BED. ON AN UNSPECIFIED DATE IN 2012, THE PATIENT'S HEALTHCARE PROFESSIONAL RECOMMENDED THE TREATMENT WITH MEDROL (METHYLPREDNISOLONE) PACK FOR THE SWELLING AND PAIN. ON AN UNSPECIFIED DATE IN 2012, THE PATIENT HAD KNEE EFFUSION, FOLLOWING WHICH HIS PHYSICIAN REMOVED TWO TUBES OF LIQUID OUT OF HIS KNEE AND GIVEN HIM A CORTISONE SHOT AS A TREATMENT. HE WAS ALSO TAKING ACETAMINOPHEN (PARACETAMOL) FOR THE RIGHT KNEE PAIN. THE PATIENT WAS RESTING THE LEG AND APPLIED ICE AND THE PAIN WAS BETTER ON (B)(6) 2012. NO ACTION WAS TAKEN WITH SYNVISC ONE. THE EVENTS OF RIGHT KNEE PAIN, RIGHT KNEE SWOLLEN/RIGHT KNEE WAS A BIG GRAPEFRUIT, AND "CANNOT PUT ANY WEIGHT ON KNEE" WAS NOT YET RECOVERED. THE OUTCOME FOR THE EVENTS OF KNEE EFFUSION AND "COULD NOT LIFT HIS FOOT" WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE WARFARIN. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention WARFARIN