BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3030357 · Received March 28, 2013

    Report

    Report Number
    2246315-2013-00062
    Event Type
    Other
    Date Received
    March 28, 2013
    Date of Event
    September 1, 2012
    Report Date
    March 19, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED AND BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. ON A PERIODIC BASIS, DATA IS 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    KNEE FLARE UP [ARTHROPATHY]. LOOSE FRAGMENT IN KNEE JOINTS [LOOSE BODY IN JOINT]. DEVICE MISUSE [DEVICE MISUSE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A FEMALE PATIENT, (B)(6), WITH OSTEOARTHRITIS OF THE KNEE. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION AT A DOSE OF 6 ML (DEVICE MISUSE), (ROUTE AND FREQUENCY NOT PROVIDED). THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2012 (TWO WEEKS FOLLOWING SYNVISC INJECTION), THE PATIENT EXPERIENCED A FLARE UP OF THE KNEE. ON AN UNSPECIFIED DATE IN (B)(6) 2012, THE PATIENT'S ARTHROSCOPY WAS DONE WHICH REVEALED LOOSE FRAGMENT IN KNEE JOINTS. AFTER RECOVERING FROM ARTHROSCOPY, THE PATIENT'S FLARING SUBSIDED AND SHE ALSO REPORTED THAT SHE HAD GOOD PAIN RELIEF FROM SYNVISC. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT RECOVERED FROM THE EVENT OF KNEE FLARE UP AND THE OUTCOME FOR THE EVENTS OF LOOSE FRAGMENT IN KNEE JOINTS AND DEVICE MISUSE WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF KNEE FLARE UP, LOOSE FRAGMENT IN KNEE JOINTS AND DEVICE MISUSE WAS NOT PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127577 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R