BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096182 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00275
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    January 1, 1998
    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]. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A (B)(6) MALE PATIENT. INITIALS UNK, WITH OSTEOARTHRITIS (KELLGREN-LAWRENCE GRADE 4 AND 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 NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT INITIATED THE FIRST COURSE OF TREATMENT WITH INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION, DOSAGE REGIMEN NOT PROVIDED, INTO THE LEFT KNEE. THE LOT FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 1998. THE PATIENT RECEIVED SECOND SYNVISC INJECTION. ON (B)(6) 1998, THE PATIENT EXPERIENCED SYNOVITIS OF LEFT KNEE. THE PATIENT ALSO EXPERIENCED SMALL-MODERATE LEFT KNEE EFFUSION AND 20 CC OF CLEAR YELLOW FLUID WAS ASPIRATED. IT WAS REPORTED THAT THE PATIENT HAD NO SIGN OF INFECTION. THE PATIENT RECEIVED TREATMENT WITH INTRA-MUSCULAR DALALONE (DEXAMETHASONE SODIUM PHOSPHATE) AT A DOSE OF 01 CC FOR THE EVENTS OF SYNOVITIS OF LEFT KNEE AND LEFT KNEE EFFUSION. THE PATIENT RECOVERED FROM SYNOVITIS OF LEFT KNEE AND LEFT KNEE EFFUSION WAS MODERATE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS OF LEFT KNEE AS DEFINITELY RELATED. THE CAUSAL RELATIONSHIP FOR THE EVENT OF LEFT KNEE EFFUSION WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178824 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention