BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3084976 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00112
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    September 12, 2002
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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; 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. MANUFACTURER'S COMMENT: THIS CASE REPORT BELONGS TO A BATCH OF ICSRS FROM A DATABASE EXTRACTION CONTAINING A COLLECTION OF DATA FROM OCTOBER 1997 TO JULY 2010. THE BENEFIT-RISK PROFILE OF THE PRODUCT IS NOT ALTERED BY THIS REPORT.

    Description of Event or Problem · 1

    SYNOVITIS, RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A FEMALE PATIENT, INITIALS UNKNOWN, WITH OSTEOARTHRITIS (KELLGREN AND LAWRENCE GRADE 3). THIS CASE BELONGS TO A BATCH OF ICSRS FROM A COMPANY PURCHASED DATABASE CONTAINING A COLLECTION OF DATA FROM OCTOBER 1997 TO JULY 2010. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC (ONE COURSE). IT WAS REPORTED THAT THE AGE OF THE PATIENT AT THE TIME OF FIRST INJECTION OF FIRST COURSE WAS (B)(6). ON (B)(6) 2002, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, (DOSAGE REGIMEN NOT PROVIDED) (SECOND COURSE), IN THE RIGHT KNEE. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2002, THE PATIENT DEVELOPED SYNOVITIS IN THE RIGHT KNEE. ON AN UNSPECIFIED IN (B)(6) 2002, THE PATIENT DEVELOPED RIGHT KNEE EFFUSION. IT WAS REPORTED THAT PATIENT'S ARTHROCENTESIS WAS PERFORMED AND NO FLUID WAS ASPIRATED. LATER, THE PATIENT WAS TREATED WITH XYLOCAINE (LIDOCAINE) AT A DOSE OF 1 CC AND INTRA-ARTICULAR BETAMETHASONE AT A DOSE OF 1.3 CC. ON (B)(6) 2002, 24 HOURS LATER, THE PATIENT RECOVERED FROM THE EVENT OF SYNOVITIS IN RIGHT KNEE. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF RIGHT KNEE EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF RIGHT KNEE EFFUSION WAS MILD. THE INTENSITY FOR THE EVENT OF SYNOVITIS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITELY RELATED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF RIGHT KNEE EFFUSION WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2013 AND THE PATIENT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180095 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention