BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 4142810 · Received September 23, 2014

    Report

    Report Number
    2246315-2014-30182
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 17, 2014
    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

    PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2014: IN THIS CASE, THE CAUSAL ROLE OF THE SUSPECT DRUG SYNVISC CANNOT BE EXCLUDED FOR THE OCCURRENCE OF THE EVENT OF BAKER'S CYST AND 20 OUNCES OF FLUID DRAWN FROM LEFT KNEE, HOWEVER, THE ROLE OF UNDERLYING MEDICAL HISTORY AND THE LACK OF INFORMATION REGARDING THE CONCOMITANT MEDICATIONS USED BY THE PATIENT PRECLUDES THE COMPLETE CASE ASSESSMENT.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(4) 2014 FROM A CONSUMER. THIS CASE CONCERNS (B)(6) FEMALE PATIENT WHO EXPERIENCED BAKER'S CYST AND HAD 20 OUNCES OF FLUID DRAWN FROM LEFT KNEE AFTER RECEIVING TREATMENT WITH SYNVISC. RELEVANT PAST MEDICAL HISTORY INCLUDED OSTEOARTHRITIS FOR YEARS AND WAS DISABLED. RELEVANT CONCOMITANT MEDICATION AND PAST DRUGS AND WERE NOT REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION, AT A DOSE OF 2 ML WEEKLY (ROUTE, LOT/BATCH NUMBER AND EXPIRATION DATE UNKNOWN) IN BOTH KNEES FOR OSTEOARTHRITIC KNEES. ON AN UNKNOWN DATE (UNKNOWN LATENCY) AFTER FIRST INJECTION, SHE EXPERIENCED SWELLING LIKE A BUBBLE, SURROUNDING BOTH KNEES. THE PATIENT DID NOT HAVE ANY SWELLING IN HER KNEES OR ANKLES PRIOR GETTING THE SYNVISC INJECTIONS. SHE SAID SHE TOLD HER PHYSICIAN ABOUT HER SYMPTOMS BUT HE STILL SUGGESTED HER TO CONTINUE AND COMPLETE THE INJECTION SERIES. ON AN UNKNOWN DATE IN (B)(6) 2014, PATIENT COMPLETED TREATMENT WITH SYNVISC INJECTION. ON AN UNKNOWN DATE IN (B)(6) 2014, THREE DAYS AFTER THE LAST INJECTION, PATIENT HAD 20 OUNCES OF FLUID DRAWN FROM HER LEFT KNEE. SHE SAID THE PHYSICIAN TOLD HER TO DRINK FLUID AND RETURN IN THREE DAYS TO REMOVE FLUID FROM THE RIGHT KNEE. THE PATIENT RETURNED AND THE PHYSICIAN COULD NOT DRAW THE FLUID FROM THE RIGHT KNEE BECAUSE THE FLUID WAS TOO THICK TO COME OUT. SHE SAID THE FLUID ALSO STARTED GOING INTO THE OUTSIDE OF BOTH HER ANKLES. SHE SAID HER PHYSICIAN INJECTED STEROIDS IN BOTH KNEES, GAVE HER BRACES FOR BOTH KNEES AND A CANE. SHE SAID SHE HAD SEEN THREE DIFFERENT SPECIALISTS ABOUT HER KNEES AND THEY COULD NOT HELP HER. THE PATIENT ALSO HAD MAGNETIC RESONANCE IMAGING OF HER KNEES THE LAST ONE WAS THREE WEEKS AGO, WHICH SHOWED THE FLUID HAS MOVED OUT OF KNEE JOINTS. SHE SAID THE FLUID WAS ON THE OUTSIDE ON THE BACK OF BOTH HER KNEES AND WAS STILL IN BOTH ANKLES. ON AN UNKNOWN DATE IN 2014, PATIENT WAS DIAGNOSED WITH BAKER CYST ON THE BACK OF BOTH KNEES THREE MONTHS AGO. SHE SAID THE SWELLING IN HER KNEES AND ANKLES WAS GOING ON SINCE SHE HAD THE SYNVISC INJECTION. SHE SAID HER ORTHOPEDIC PHYSICIAN TOLD HER TO CHECK WITH A VASCULAR PHYSICIAN OF A RHEUMATOLOGIST ABOUT THE SWELLING IN HER KNEES AND ANKLES. AT THE TIME OF REPORTING, PATIENT SYMPTOMS WERE CONTINUING. ACTION TAKEN: NO ACTION TAKEN. CORRECTIVE TREATMENT: CORTICOSTEROID NOS (STEROIDS). OUTCOME: NOT RECOVERED/ NOT RESOLVED FOR BOTH EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR BOTH EVENTS. NO FURTHER INVESTIGATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591074 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PREV MEDS = UNK| CON MEDS = UNK