BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC

    MDR report key: 772980 · Received October 20, 2006

    Report

    Report Number
    2246315-2006-00090
    Date Received
    October 20, 2006
    Date of Event
    January 22, 2005
    Report Date
    June 13, 2006
    Manufacturer
    *
    Product Code
    MOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PSEUDOSPEPSIS OF THE KNEE. A PUBLISHED ARTICLE IN UNITED KINGDOM ENTITLED "A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL COMPARING THE EFFICACY OF HYLAN G-F 20 AND SODIUM HYALURONATE IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE" ANNALS OF THE RHEUMATIC DISEASES 2006; 65 (SUPP1 II): 403 (R.RAMAN, A.DUTTA, N.DAY, C.J.SHAW, G.V.JOHNSON) WAS RECEIVED ON 13 JUNE 2006. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE CLINICAL EFFECTIVENESS, FUNCTIONAL OUTCOME AND PATIENT SATISFACTION FOLLOWING INTRA ARTICULAR INJECTION WITH SYNVISC AND HYALGAN, IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE. IN THIS STUDY, 348 PATIENTS WERE RANDOMIZED INTO TWO GROUPS TO RECEIVED EITHER HYLAN G-F 20 - SYNVISC (N=181) OR SODIUM HYALURONATE - HYALGAN (N=167). ALL PATIENTS WERE TO RECEIVE THE RECOMMENDED DOSES (I.E. 3 WEEKLY INJECTIONS SYNVISC OR 5 WEEKLY INJECTIONS OF HYALGAN) WHICH WERE ADMINISTERED BY THE SAME PHYSICIAN USING THE DEFAULT TECHNIQUE. ALL PATIENTS WERE PROSPECTIVELY REVIEWED BY INDEPENDENT ASSESSORS WHO WERE BLINDED FOR THE TREATMENT AT PRE INJECTION, 6 WEEKS, 3 AND 6 MONTHS AND YEARLY THEREAFTER. VAS WAS USED TO QUANTIFY PATIENT SATISFACTION. THE MEAN FOLLOW UP WAS 12 MONTHS. THE AUTHORS REPORTED LOCAL REACTION OF PSEUDOSEPSIS IN ONE PATIENT TREATED WITH SYNVISC. THE OUTCOME WAS UNKNOWN AND THE AUTHOR DID NOT PROVIDE A CAUSALITY ASSESSMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 27-SEP-2006 FROM THE AUTHOR OF THE ARTICLE REGARDING A FEMALE PATIENT WITH HISTORY OF OSTEOARTHRITIS IN THE KNEE WHO EXPERIENCED PSEUDOSEPSIS OF THE KNEE. THE PATIENT RECEIVED TWO SYNVISC INJECTIONS INTO THE KNEE IN 2005. THE PATIENT DEVELOPED SEVERE PAIN AND SYNOVIAL EFFUSION IN THE KNEE. THE PHYSICIAN DESCRIBED THE EVENT AS AN ACUTE EXACERBATION OF OSTEOARTHRITIS WITH SYNOVITIS. THE PATIENT WAS ADMITTED TO HOSPITAL FOR PAIN MANAGEMENT AND TO RULE OUT SEPSIS IN THE KNEE. THE WITHDRAWN EFFUSION (DETAILS NOT PROVIDED) WAS STERILE. THE PATIENT'S PAIN WAS TREATED WITH MORPHINE, DICLOFENAC SODIUM AND PARACETAMOL. TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. THE AUTHOR ASSESSED THE EVENT AS BEING NON-SERIOUS AND THE SEVERITY OF THE EVENT AS SEVERE. THE RELATIONSHIP BETWEEN THE EVENT AND THE USE OF SYNVISC WAS ASSESSED AS DEFINITELY RELATED. THE PATIENT RECOVERED. OTHER EVENTS REPORTED BY THE AUTHOR. MORPHINE 30 MG FOR MANAGEMENT OF PAIN, DICLOFENAC SODIUM 150 MG FOR MANAGEMENT OF PAIN, PARACETAMOL 2 GR FOR MANAGEMENT OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ * NA Y0402

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization