BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3032764 · Received March 25, 2013

    Report

    Report Number
    2246315-2013-00059
    Event Type
    Other
    Date Received
    March 25, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 18, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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.

    Description of Event or Problem · 1

    KNEE INFECTION/PSEUDOSEPTIC INFECTION [ARTHRITIS INFECTIVE]. PSEUDOSEPSIS [PSEUDOSEPSIS]. ASPIRATED ABOUT 4 CC OF FLUID OFF THE KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN VIA A SALES REP REGARDING A FEMALE PT (AGE NOT PROVIDED), INITIALS UNK, WITH KNEE PAIN. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC (03 INJECTION SERIES) MORE THAN 6 MONTHS AGO. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH FIRST SYNVISC (HYLAN GF-20) INJECTION AT A DOSE OF 2 ML IN AN UNSPECIFIED KNEE (ROUTE OF ADMINISTRATION AND FREQUENCY NOT PROVIDED). ON AN UNSPECIFIED DATE, THE PT RECEIVED SECOND SYNVISC INJECTION AT A DOSE OF 2 ML. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2013, THE PT EXPERIENCED PSEUDOSEPTIC INFECTION AFTER THE SECOND SYNVISC INJECTION. ON AN UNSPECIFIED DATE, THE PHYSICIAN 'ASPIRATED ABOUT 04 CC OF FLUID OFF THE KNEE.' THE COMPANY ASSESSED THE EVENT OF KNEE INFECTION/PSEUDOSEPTIC INFECTION AS MEDICALLY SIGNIFICANT. IT WAS REPORTED THAT IT WAS NOT KNOWN WHETHER THE PT RECEIVED THIRD SYNVISC INJECTION. THE OUTCOME AND INTENSITY FOR THE EVENTS OF KNEE INFECTION/PSEUDOSEPTIC INFECTION, PSEUDOSEPSIS AND 'ASPIRATED ABOUT 4 CC OF FLUID OFF THE KNEE' WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS REPORTED TRAMADOL AND CORTICOSTEROID NOS. THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122907 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other TRAMADOL (TRAMADOL)| CORTICOSTEROID NOS (CORTICOSTEROID NOS)