BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1053300 · Received May 28, 2008

    Report

    Report Number
    2246315-2008-00079
    Date Received
    May 28, 2008
    Date of Event
    February 4, 2008
    Report Date
    April 21, 2008
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY 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

    SYNOVITIS RIGHT KNEE [SYNOVITIS]. CONSTRAINED MOVEMENT(KNEE) [MOBILITY DECREASED]. KNEE IRRITATION [MUSCULOSKELETAL DISCOMFORT]. KNEE SWELLING [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. HYPERTHERMIA [HYPERTHERMIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 21-APR-2008 FROM A PHYSICIAN REGARDING A PT, (INITIALS, GENDER, AGE, AND MEDICAL HISTORY UNK), WHO EXPERIENCED A KNEE IRRITATION. THE PT RECEIVED UNK NUMBER OF SYNVISC INJECTIONS. ON AN UNKNOWN DATE FOLLOWING THE SECOND INJECTION THE PT EXPERIENCED KNEE IRRITATION. A PUNCTURE OF A KNEE DID NOT SHOW ANY INFECTION. AT THE TIME OF THIS REPORT, THE PT OUTCOME WAS UNK. ON THE PREVIOUS MONTH, QA RESULTS WERE RECEIVED: 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 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. ADD'L INFO RECEIVED ON 20-MAY-2008 FROM A PHYSICIAN REGARDING A PT WITH A MEDICAL HISTORY OF KNEE OSTEOARTHRITIS. FIVE MONTHS PRIOR AND THE FOLLOWING MONTH, THE PT RECEIVED THE FIRST AND THE SECOND SYNVISC INJECTION. FOLLOWING THE SECOND INJECTION HE EXPERIENCED SERIOUS SYNVOVITIS IN THE RIGHT KNEE WITH A SYMPTOMS' OF: INTENSE SWELLING, CONSTRAINED MOVEMENT, AND HYPERTHERMIA. THE LAB TEST RESULTS SHOWED A BSR (ERYTHROCYTE SEDIMENTATION RATE) OF 36, AND CRP (C-REACTIVE PROTEIN) OF 6,3. A PUNCTURE OF A KNEE DID NOT SHOWED ANY INFECTION AND WAS WITHOUT GERMS. THE PT WAS CORRECTIVELY TREATED WITH THE CORTICOSTEROID LIPOTALON. AT THE TIME OF THIS REPORT THE PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION NONE MOZ GENZYME BIOSURGERY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other