BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3096129 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00223
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    February 13, 2006
    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. 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: (B)(4). THE BENEFIT RISK PROFILE OF THE PRODUCT IS NOT ALTERED BY THIS REPORT.

    Description of Event or Problem · 1

    SYNOVITIS [SYNOVITIS]. JOINT EFFUSION OF LEFT KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A (B)(6) FEMALE PATIENT, INITIALS: UNKNOWN WITH OSTEOARTHRITIS (KELLGREN-LAWRENCE GRADE 4). (B)(4). THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN 2006, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC (HYLAN G F 20) INJECTION IN LEFT KNEE, DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2006, THE PATIENT RECEIVED THIRD INJECTION OF SYNVISC. ON (B)(6) 2006, THE PATIENT EXPERIENCED SYNOVITIS. ON AN UNSPECIFIED DATE IN (B)(6) 2006, THE PATIENT HAD EFFUSION OF LEFT KNEE AND 40 CC OF SLIGHT TURBID FLUID WAS ASPIRATED. ON AN UNSPECIFIED DATE IN (B)(6) 2006, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR BETAMETHASONE AT A DOSE OF 1.5 CC (FREQUENCY NOT PROVIDED). ON (B)(6) 2006 (48 HRS DURATION), THE EVENT OF SYNOVITIS RESOLVED. THE OUTCOME FOR THE EVENT OF JOINT EFFUSION OF LEFT KNEE WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SYNOVITIS WAS SEVERE AND FOR THE EVENT OF JOINT EFFUSION OF LEFT KNEE WAS MODERATE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITELY RELATED AND DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF JOINT EFFUSION OF LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179004 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention