BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2214101 · Received July 18, 2011

    Report

    Report Number
    2246315-2011-00174
    Event Type
    Other
    Date Received
    July 18, 2011
    Report Date
    July 11, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    EFFUSION OF KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A PHYSICIAN, REGARDING A MALE PT (INITIALS UNKNOWN). THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR BILATERAL GONARTHRITIS AND AT LEAST ONE SERIES OF SYNVISC (3X2 ML) IN THE PAST WITHOUT INCIDENTS. ON AN UNSPECIFIED DATE, THE PT INITIATED SYNVISC-ONE INJECTIONS OF 6 ML INTO BOTH KNEES UNDER ULTRASOUND CONTROL IMAGING. THE SYNVISC-ONE LOT NUMBER WAS NOT PROVIDED. AROUND 24 HOURS AFTER RECEIVING THE SYNVISC-ONE INJECTIONS, THE PT EXPERIENCED KNEE JOINT EFFUSION ON ONE KNEE. ON AN UNSPECIFIED DATE, THE PT'S KNEE WAS ASPIRATED OF 120 ML OF STERILE FLUID AND INJECTED WITH CORTICOSTEROIDS. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS NOT PROVIDED. THE PT'S OUTCOME FOR THE EVENT OF EFFUSION OF KNEE WAS REPORTED AS NOT YET RECOVERED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC-ONE AND THE EVENT OF EFFUSION OF KNEE WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2011, IN THE FORM OF A QA INVESTIGATION 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 OUT OF 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention