BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096284 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00147
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    January 1, 2001
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    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. 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]. RIGHT KNEE EFFUSION [JOINT EFFUSION]. ARTHROSCOPY. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A PATIENT, INITIALS UNK, 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 NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION, (DOSAGE REGIMEN NOT PROVIDED) (FIRST SERIES), INTO BOTH KNEES. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2001, THE PATIENT RECEIVED THIRD SYNVISC INJECTION OF THE FIRST COURSE. ON (B)(6) 2001, THE PATIENT DEVELOPED SYNOVITIS IN BOTH THE KNEES. ON UNSPECIFIED DATES IN 2001, 20 CC OF CLEAR YELLOW FLUID WAS ASPIRATED FROM THE LEFT KNEE AND 26CC OF CLEAR FLUID FROM THE RIGHT KNEE. LATER, THE PATIENT WAS TREATED WITH INTRA-ARTICULAR CELESTONE (BETAMETHASONE) AT A DOSE OF 1 CC AND XYLOCAINE (LIDOCAINE) AT A DOSE OF 1CC. ON (B)(6) 2001, THE PATIENT RECOVERED FROM THE EVENT OF SYNOVITIS IN BOTH THE KNEES. ON (B)(6) 2001, THE PATIENT UNDERWENT ARTHROSCOPY OF LEFT KNEE. THE OUTCOME FOR THE EVENTS OF LEFT KNEE EFFUSION, RIGHT KNEE EFFUSION AND ARTHROSCOPY WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF SYNOVITIS OF BOTH KNEES AND LEFT KNEE EFFUSION WAS MODERATE AND FOR THE EVENT OF RIGHT KNEE EFFUSION WAS SEVERE. THE INTENSITY FOR THE EVENT OF ARTHROSCOPY WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS IN BOTH KNEES AS DEFINITELY RELATED AND WITH THE EVENT OF ARTHROSCOPY AS UNRELATED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF LEFT KNEE EFFUSION AND RIGHT KNEE EFFUSION WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. FOLLOW-UP INFO WAS RECEIVED ON (B)(6) 2013 AND THE PATIENT'S INITIALS ERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179130 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention