BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096057 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00143
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    January 1, 2004
    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. EVAL SUMMARY: THE PRODUCT 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 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 [SYNOVITIS]. LEFT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A (B)(6) FEMALE PT, INITIAL UNK WITH OSTEOARTHRITIS (KELLGREN-LAWRENCE GRADE III). 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 PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC (FIRST COURSE). ON UNSPECIFIED DATES IN (B)(6) 2004, THE PT INITIATED TREATMENT WITH SECOND COURSE OF INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION IN LEFT KNEE, DOSAGE REGIMEN NOT PROVIDED. ON (B)(6) 2004, THE PT RECEIVED HER THIRD SYNVISC INJECTION. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2004, THE PT EXPERIENCED SYNOVITIS OF LEFT KNEE. ON AN UNSPECIFIED DATE IN (B)(6) 2004, 45 CC OF FLUID WAS ASPIRATED (YELLOW TURBID) FROM THE LEFT KNEE (LEFT KNEE EFFUSION) AND THE PT WAS TREATED WITH INTRA-ARTICULAR BETAMETHASONE AT A DOSE OF 1.3 CC FOR SYNOVITIS AND LEFT KNEE EFFUSION. ON (B)(6) 2004, THE PT RECOVERED FROM THE EVENT OF SYNOVITIS OF LEFT KNEE. THE OUTCOME FOR THE EVENT OF LEFT KNEE EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR BOTH THE EVENTS WAS SEVERE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS OF LEFT KNEE AS DEFINITELY RELATED AND DID NOT PROVIDE THE RELATIONSHIP WITH THE EVENT OF LEFT KNEE EFFUSION. FOLLOW-UP INFO WAS RECEIVED ON (B)(6) 2013 AND THE PT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179016 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention