BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096301 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00200
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    March 1, 2001
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    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 OCT 1997 TO JUL 2010. THE BENEFIT RISK PROFILE OF THE PRODUCT IS NOT ALTERED BY THIS REPORT.

    Description of Event or Problem · 1

    SYNOVITIS. HEMARTHROSIS OF RIGHT KNEE [HAEMARTHROSIS]. CASE DESCRIPTION: CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A (B)(6) FEMALE, INITIALS UNK, WITH OSTEOARTHRITIS. THIS CASE BELONGS TO A BATCH OF ICSRS FROM A COMPANY PURCHASED DATABASE CONTAINING A COLLECTION OF DATA FROM OCT 1997 TO JUL 2010. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2001, THE PT INITIATED TREATMENT WITH FIRST INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION IN RIGHT KNEE, DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2001, THE PT EXPERIENCED SYNOVITIS. ON AN UNSPECIFIED DATE IN (B)(6) 2001, 20 CC FLUID WAS ASPIRATED FROM THE RIGHT KNEE WHICH WAS BLOODY (HEMARTHROSIS). THE PT RECEIVED TREATMENT WITH INTRA-ARTICULAR CELESTONE (BETAMETHASONE) AT A DOSE OF 02 CC AND XYLOCAINE (LIDOCAINE), AT A DOSE OF 01 CC FOR THE EVENTS OF SYNOVITIS AND HEMARTHROSIS OF RIGHT KNEE. ON (B)(6) 2001 THE PT RECOVERED FROM THE EVENT OF SYNOVITIS. ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF HEMARTHROSIS OF RIGHT KNEE WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SYNOVITIS WAS MODERATE AND SEVERE FOR THE EVENT OF HEMARTHROSIS OF RIGHT KNEE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITE AND DID NOT PROVIDE THE RELATIONSHIP WITH HEMARTHROSIS OF RIGHT KNEE. ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2013 AND THE PT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179168 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention