BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 2153075 · Received June 23, 2011

    Report

    Report Number
    2410673-2011-00004
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    June 24, 2011
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    950027
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2011: A (B)(6) MALE CONSUMER UNDERWENT SURGERY IN (B)(6) 2010 TO REPAIR THE MENISCUS IN HIS RIGHT KNEE. HE EXPERIENCED A LOT OF SWELLING IN THE KNEE AND IT WAS DRAINED 8 TIMES. HE WAS THEN TREATED WITH SODIUM HYALURONATE (HYALGAN) (LOT # UNKNOWN, EXPIRATION DATE UNKNOWN) IN THE KNEE IN (B)(6) 2010. HE REPORTED THAT HE EXPERIENCED SWELLING AND TIGHTNESS RIGHT AWAY. HE STATED THAT HE DEVELOPED CYSTS UNDER HIS RIGHT KNEE CAP THAT MOVED DOWN HIS RIGHT LEG. HE HAD TWO ADDITIONAL SURGERIES BECAUSE THE DOCTORS FELT THAT SOMETHING WAS LEFT BEHIND IN THE FIRST SURGERY. AFTER THE LAST SURGERY (6-7 MONTHS AGO) THE "TWO BUBBLES BECAME MANY BUBBLES." HE STATED THAT THEY FELT LIKE "BUBBLES OF SILICONE." HE HAD LIMITED LEG MOVEMENT BECAUSE OF HIS KNEE AND HAD SEVERE KNEE PAIN AT NIGHT. HE ADDED THAT HE WAS LOSING MUSCLE ABOVE HIS RIGHT KNEE. HE WENT ON TO STATE THAT SODIUM HYALURONATE WAS A BIG MISTAKE AND HE MAY HAVE TO GO TO THE NEXT LEVEL AND HIRE AN ATTORNEY. NO FURTHER RELEVANT INFORMATION REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENTS: THIS CASE IS CONFOUNDED BY THE PREVIOUS HISTORY OF KNEE SURGERY TO REPAIR A MENISCUS. ADDITIONAL INFORMATION IS NEEDED (E.G. PERI-OPERATIVE FINDINGS AND POST-OPERATIVE DIAGNOSIS, COMPLETE MEDICAL HISTORY, CONCOMITANT DIAGNOSIS, ETC.) TO MAKE A COMPLETE MEDICAL AND CAUSAL ASSESSMENT. IN ADDITION, THE REPORTER INDICATED HE WENT FOR ADDITIONAL SURGERIES BECAUSE HIS "DOCTORS FELT THERE WAS SOMETHING LEFT BEHIND" AFTER HIS FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other PREV MEDS = UNKNOWN| CON MEDS = UNKNOWN