BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2757769 · Received September 20, 2012

    Report

    Report Number
    2246315-2012-00292
    Event Type
    Other
    Date Received
    September 20, 2012
    Date of Event
    December 14, 2011
    Report Date
    September 11, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL: THE 4TH JAPAN ORTHOPAEDIC SURGERY SOCIETY ON KNEE/ARTHROSCOPY/SPORTS. AUTHOR: KURIYAMA S, MOMONA K, TAMAOKI Y, ET AL. TITLE: EFFICACY AND COMPLICATIONS OF HYLAN G-F20 IN OSTEOARTHRITIC KNEES. VOLUME: 37(4), YEAR: 2012, PAGES: 169. ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2012 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEWED 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: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    NON-INEFFECTIVE JOINT FLUID RETENTION [JOINT EFFUSION]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM AN AUTHOR REGARDING A (B)(6) FEMALE PT, (INITIAL: NOT PROVIDED), WITH GONARTHROSIS OF BOTH KNEES. THIS REPORT IS FROM A LITERATURE ARTICLE ENTITLED "EFFICACY AND COMPLICATIONS OF HYLAN G-F20 IN OSTEOARTHRITIC KNEES". THE PT'S MEDICAL HISTORY WAS SIGNIFICANT PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC ((B)(6)). ON (B)(6) 2011, THE PT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F20) INJECTION AT A DOSE OF 2 ML/MONTH INTO BOTH KNEES. ON AN UNSPECIFIED DATE IN (B)(6) 2011, THE PT RECEIVED THE SECOND SYNVISC INJECTION. ON (B)(6) 2011, THE PT RECEIVED THE THIRD SYNVISC INJECTION. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2011, THE PT DEVELOPED JOINT FLUID RETENTION IN BOTH KNEES. THE PT VISITED EMERGENCY ROOM OF THE HOSPITAL, BUT FLUID RETENTION WAS NOT VACUUMED. THE PT WAS PRESCRIBED WITH ANALGESIC DRUG AND UNSPECIFIED FOMENTATION WITH DOCTOR'S INSTRUCTION TO KEEP RESTING. IT WAS REPORTED THAT THE EVENT WAS ASEPTIC AND ALLEVIATED WITH RESTING AND TRANQUILIZERS. ON (B)(6) 2011, THE PT RECOVERED FROM THE EVENT OF NON-INFECTIVE JOINT FLUID RETENTION. RELEVANT CONCOMITANT MEDICATION WAS NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT AS DEFINITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention