BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2860510 · Received December 5, 2012

    Report

    Report Number
    2246315-2012-00372
    Event Type
    Other
    Date Received
    December 5, 2012
    Date of Event
    November 2, 2011
    Report Date
    November 21, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA 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 THIS REPORT.

    Description of Event or Problem · 1

    SWELLING OF LEFT KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A (B)(6) WITH GONARTHROSIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OSTEOPOROSIS (COMPLICATION DISEASE) AND PREVIOUS USE OF SYNVISC FROM (B)(6) 2011 (FIRST COURSE, SECOND INJECTION ON (B)(6) 2011). ON (B)(6) 2011, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION (HYLAN GF-20), (ROUTE AND DOSE NOT PROVIDED, SECOND COURSE) AT A FREQUENCY OF ONCE PER WEEK, IN AN UNSPECIFIED LOCATION. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2011, THE PATIENT VISITED OUT-PATIENT OF A CLINIC FOR SWELLING OF LEFT KNEE (FIRST EPISODE). ON THE SAME DAY, SHE RECEIVED TREATMENT WITH TRIAMCINOLONE AND LIDOCAINE HYDROCHLORIDE AS TREATMENT. ON (B)(6) 2011, THE SWELLING OF LEFT RESOLVED AND THE PATIENT RECEIVED THE SECOND INJECTION OF SYNVISC. ON 1(B)(6) 2011, THE PATIENT RECEIVED THE THIRD INJECTION OF SYNVISC. ON (B)(6) 2011, THE PATIENT VISITED THE OUT-PATIENT OF THE CLINIC FOR SWELLING OF LEFT KNEE AGAIN (SECOND EPISODE). ON THE SAME DAY, SHE RECEIVED TREATMENT WITH TRIAMCINOLONE AND LIDOCAINE HYDROCHLORIDE AS TREATMENT AGAIN. SYNVISC DOSE WAS UNCHANGED. ON (B)(6) 2011, AT THE OUT-PATIENT CLINIC, IT WAS CONFIRMED THAT THE SWELLING HAD DISAPPEARED (SECOND EPISODE). RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE ALENDRONATE SODIUM HYDRATE. THE INTENSITY FOR BOTH THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND BOTH THE EVENTS AS PROBABLE.

    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