BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2163626 · Received June 10, 2011

    Report

    Report Number
    2246315-2011-00136
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    March 30, 2011
    Report Date
    June 2, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ARTHRITIS [ARTHRITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011, FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH ARTHRITIS. THE PHYSICIAN REPORTED THAT THE PT RECEIVED SYNVISC. THE LOCATION, NUMBER OF INJECTIONS AND DATES OF ADMINISTRATION WERE NOT PROVIDED. ON (B)(6) 2011, THE PT DEVELOPED ARTHRITIS. THE PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN THE EVENT AND SYNVISC AS DEFINITE. THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS RECOVERED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011, FROM THE PHYSICIAN, WHICH UPGRADED THE CASE TO SERIOUS. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR GONARTHROSIS (BOTH KNEES), HYPERTENSION AND HEBERDEN'S NODES ON BOTH HANDS. ON (B)(6) 2011, THE PT RECEIVED THE FIRST INJECTION OF SYNVISC IN HER RIGHT KNEE. AFTER THE INJECTION, THE PT DEVELOPED KNEE PAIN AND A HOT FEELING. ON (B)(6) 2011, THE PT RECEIVED THE SECOND INJECTION OF SYNVISC IN HER RIGHT KNEE "FROM OUT SIDE OF THE KNEE," BUT PAIN AGAIN DEVELOPED IN THE KNEE. THE PHYSICIAN DIAGNOSED THE PT WITH ARTHRITIS. ON (B)(6) 2011, THE PT BEGAN TREATMENT WITH CELECOXIB (DOSAGE AND DURATION NOT PROVIDED). ON (B)(6) 2011, THE PT UNDERWENT AN MRI OF HER RIGHT KNEE AND SODIUM HYALURONATE WAS ADMINISTERED AS TREATMENT ALONG WITH DEXAMETHASONE SODIUM PHOSPHATE. THE PHYSICIAN REPORTED THAT SODIUM HYALURONATE AND DEXAMETHASONE SODIUM PHOSPHATE WERE BOTH AGAIN ADMINISTERED ON (B)(6) 2011. SODIUM HYALURONATE WAS ADMINISTERED ON (B)(6) 2011 AND AGAIN ON (B)(6) 2011, SODIUM HYALURONATE WAS ADMINISTERED TWO FINAL TIMES. THE HCP REPORTED THAT THE PT RECOVERED FROM THE EVENT OF ARTHRITIS ON (B)(6) 2011. CONCOMITANT MEDICATIONS INCLUDED AMLODIPINE BESILATE, AN ON-GOING TREATMENT FOR HYPERTENSION. THE PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN THE EVENT OF ARTHRITIS AND SYNVISC AS DEFINITE. THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS RECOVERED.

    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 71 YR Required Intervention