BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1053031 · Received May 27, 2008

    Report

    Report Number
    2246315-2008-00078
    Date Received
    May 27, 2008
    Date of Event
    March 9, 2008
    Report Date
    April 21, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. AN 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.AE.

    Description of Event or Problem · 1

    EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS), SYNOVITIS RIGHT KNEE [SYNOVITIS], CONSTRAINED MOVEMENT [MOBILITY DECREASED], KNEE IRRITATION [MUSCULOSKELETAL DISCOMFORT], KNEE SWELLING [JOINT SWELLING], HYPERTHERMIA [HYPERTHERMIA], KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT REC'D ON 04/21/08 FROM A PHYSICIAN REGARDING A PT, (INITIALS, GENDER, AGE, AND MEDICAL HISTORY UNKNOWN), WHO EXPERIENCED A KNEE IRRITATION. THE PT REC'D UNKNOWN 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 UNKNOWN. ON 05/08/2008, QA RESULTS WERE REC'D: 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. ADDITIONAL INFO REC'D ON 05/20/08 FROM A PHYSICIAN REGARDING A (B) (6) FEMALE PT (B) (6), WITH A MEDICAL HISTORY OF KNEE OSTEOARTHRITIS. ON (B) (6) AND (B) (6), THE PT REC'D THE FIRST AND THE SECOND SYNVISC INJECTION. FOLLOWING THE SECOND INJECTION SHE EXPERIENCED SERIOUS SYNOVITIS IN THE RIGHT KNEE WITH SYMPTOMS' OF: INTENSE SWELLING, CONSTRAINED MOVEMENT, AND HYPERTHERMIA(37,8). THE LAB TEST RESULTS SHOWED A CRP (C-REACTIVE PROTEIN) OF 71. A PUNCTURE OF A KNEE DID NOT SHOW ANY INFECTION, AND WAS WITHOUT GERMS. THE PT WAS CORRECTIVELY TREATED WITH ARTERIOSCOPIC LAVAGE AND ANTIBIOTICS THERAPY. THE PHYSICIAN ASSESSED THE CAUSALITY AS PROBABLE. 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 (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other