BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1053016 · Received May 27, 2008

    Report

    Report Number
    2246315-2008-00077
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 20, 2008
    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

    EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED THEREFORE A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    COULD NOT WALK [ABASIA]. FLUID BUILD-UP IN BOTH KNEES [JOINT EFFUSION]. PAIN IN BOTH KNEES [ARTHRALGIA]. COULD HARDLY STAND [MOBILITY DECREASED]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 20-MAY-2008 FROM A FEMALE PT WHO HAD A RELEVANT MEDICAL HISTORY OF OSTEOARTHRITIS IN BOTH KNEES AND BOTH PATELLAS AND PREVIOUS SYNVISC THERAPY IN 2007 (3 INJECTIONS 1 WEEK APART, AND THE INJECTIONS WORKED WELL.) THE PT RECEIVED HER FIRST INJECTION ON SYNVISC IN BOTH KNEES SOMETIME IN 2008 (EXACT DATE NOT SPECIFIED). SHE RECEIVED THE SECOND INJECTION IN BOTH KNEES 1 WEEK AFTER THE FIRST INJECTION (SAME MONTH). AFTER THE SECOND INJECTION IN BOTH KNEES, THE PT EXPERIENCED "HORRIBLE PAIN" AND FLUID BUILD-UP IN BOTH KNEES AND SHE COULD NOT WALK FOR 2 DAYS. SHE RECEIVED CORTICOSTEROID INJECTIONS ( PRODUCT NOT SPECIFIED), WHICH RELIEVED THE PAIN. THE THIRD INJECTION WAS POSTPONED FOR 4 WEEKS DUE TO THE REACTION IN BOTH KNEES. SHE RECEIVED THE THIRD INJECTION OF SYNVISC IN BOTH KNEES THE FOLLOWING MONTH. AFTER THE THIRD INJECTION WAS RECEIVED, SHE AGAIN EXPERIENCED "HORRIBLE PAIN" IN BOTH KNEES AND SHE COULD "HARDLY STAND OR WALK." THE PT TREATED THE PAIN WITH REST, ICE AND IBUPROFEN. SHE HAD REPORTED HER SYMPTOMS TO THE TREATING PHYSICIAN'S OFFICE, BUT HAD NOT YET MADE AN APPOINTMENT TO GO IN FOR TREATMENT. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS NOT YET 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention