BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3084972 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00096
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    December 3, 2002
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME BIOSURGERY
    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. MFR'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. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN, WITH OSTEOARTHRITIS (WITH NO PRIOR EFFUSION). 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 USE WITH SYNVISC (02 COURSES), SYNOVITIS, PREVIOUS TREATMENT WITH XYLOCAINE AND BETAMETHASONE, AND RIGHT KNEE EFFUSION. THE PATIENT'S AGE WAS REPORTED TO BE (B)(6) AT THE TIME OF FIRST COURSE OF SYNVISC IN RIGHT KNEE. ON (B)(6) 2002, THE PATIENT INITIATED TREATMENT WITH FIRST INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION OF THE THIRD COURSE IN LEFT KNEE (DOSAGE REGIMEN NOT PROVIDED). THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2002, THE PATIENT DEVELOPED SYNOVITIS IN LEFT KNEE. ON AN UNSPECIFIED DATE IN (B)(6) 2002, THE PATIENT HAD LEFT KNEE EFFUSION AND UNKNOWN AMOUNT OF JOINT FLUID WAS ASPIRATED. THE PATIENT WAS TREATED WITH XYLOCAINE (LIDOCAINE) AND BETAMETHASONE FOR THE EVENTS OF SYNOVITIS IN LEFT KNEE AND LEFT KNEE EFFUSION. ON (B)(6) 2002, 24 HOURS LATER, THE PATIENT RECOVERED FROM SYNOVITIS IN LEFT KNEE. THE ACTION TAKEN WITH SYNVISC WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF LEFT KNEE EFFUSION WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SYNOVITIS IN LEFT KNEE WAS MILD AND MODERATE FOR THE EVENT OF LEFT KNEE EFFUSION. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS IN LEFT KNEE AS DEFINITELY RELATED AND DID NOT PROVIDE THE RELATIONSHIP WITH THE EVENT OF LEFT KNEE EFFUSION. 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
    178896 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention