BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3085065 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00250
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    May 19, 2005
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    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 15-APR-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. MANUFACTURER'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 [SYNOVITIS], LEFT KNEE EFFUSION [JOINT EFFUSION], TOTAL KNEE REPLACEMENT [KNEE ARTHROPLASTY]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A MALE PATIENT, INITIALS UNKNOWN WITH OSTEOARTHRITIS (GRADE 4). 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 PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC (FIRST AND SECOND COURSE). AT THE TIME OF RECEIVING FIRST COURSE THE PATIENT WAS (B)(6). ON AN UNSPECIFIED DATE, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR INJECTION OF SYNVISC (HYLAN GF-20) IN LEFT KNEE (DOSAGE REGIMEN NOT PROVIDED). THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2005, THE PATIENT RECEIVED SECOND INJECTION OF SYNVISC. ON (B)(6) 2005, THE PATIENT DEVELOPED SYNOVITIS OF LEFT KNEE. ON AN UNSPECIFIED DATE IN 2005, 65 CC OF TURBID YELLOW JOINT FLUID WAS ASPIRATED FROM LEFT KNEE. THE PATIENT RECEIVED TREATMENT WITH 1.3 CC BETAMETHASONE. ON (B)(6) 2005 (48 HOURS LATER), THE EVENT OF SYNOVITIS RECOVERED. ON (B)(6) 2005, THE PATIENT RECEIVED THIRD INJECTION OF SYNVISC. ON (B)(6) 2005, THE PATIENT UNDERWENT TOTAL KNEE REPLACEMENT OF LEFT KNEE. THE OUTCOME OF JOINT EFFUSION AND TOTAL KNEE REPLACEMENT WAS NOT PROVIDED. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. RELEVANT CONCOMITANT WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SYNOVITIS AND LEFT KNEE EFFUSION WAS SEVERE AND THE INTENSITY OF TOTAL KNEE REPLACEMENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC WITH SYNOVITIS AS DEFINITELY RELATED AND DID NOT PROVIDE A CAUSAL RELATIONSHIP WITH LEFT KNEE EFFUSION AND TOTAL KNEE REPLACEMENT. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2013 AND THE PATIENT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179538 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention