BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1834077 · Received August 11, 2010

    Report

    Report Number
    2246315-2010-00157
    Date Received
    August 11, 2010
    Report Date
    June 30, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. ON 03-AUG-2010, THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER P10072, EXPIRATION DATE 01/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    LEFT KNEE SWELLING [JOINT SWELLING], KNEE EFFUSION [JOINT EFFUSION], THROMBOPHLEBITIS [THROMBOPHLEBITIS], PAIN ON LEFT CALF [PAIN IN EXTREMITY], FEVER [PYREXIA], SWELLING OF LEFT CALF [OEDEMA PERIPHERAL], LEFT BAKER CYST RUPTURE [SYNOVIAL RUPTURE], BAKER CYST ON RIGHT KNEE [SYNOVIAL CYST], RIGHT KNEE PAIN [ARTHRALGIA]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2010 FROM A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH A HISTORY OF GONARTHRITIS WHO EXPERIENCED LEFT KNEE AND CALF SWELLING, FEVER, LEFT BAKER CYST RUPTURE, KNEE EFFUSION AS WELL AS THROMBOPHLEBITIS AFTER TREATMENT WITH SYNVISC. THE PATIENT ALSO WAS NOTED TO HAVE A RIGHT BAKER'S CYST. THE PATIENT HAD A HISTORY OF PREVIOUS TREATMENT WITH SYNVISC (2007). FOR THE CURRENT SERIES OF SYNVISC, THE PATIENT RECEIVED INJECTIONS INTO BOTH KNEES ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED FEVER, KNEE SWELLING AND SWELLING OF THE LEFT CALF. TREATMENT INCLUDED ACETAMINOPHEN AND KETOPROFEN. ON (B)(6) 2010, THE PATIENT UNDERWENT BILATERAL DOPPLER ULTRASOUNDS AND "INFERIOR" LIMB ULTRASOUND EXAMINATIONS. A VERY SMALL BAKER CYST IN THE RIGHT KNEE WAS NOTED ALONG WITH A RUPTURED LEFT BAKER CYST AND THROMBOPHLEBITIS LOCALIZED IN THE LEFT CALF. THE PATIENT WAS TREATED WITH ENOXAPARIN (ONE INJECTION ON (B)(6) 2010 AND ONE INJECTION ON (B)(6) 2010). ON (B)(6) 2010, ARTHROCENTESIS WAS PERFORMED ON THE LEFT KNEE WITH APPROXIMATELY 30 ML OF EFFUSION REMOVED. ANALYSIS REVEALED THAT THE FLUID WAS STERILE. THE THIRD INJECTIONS OF SYNVISC WERE NOT GIVEN. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED FROM THE EVENTS OF EFFUSION AND BAKER CYST RUPTURE. THE PATIENT WAS RECOVERING FROM THE EVENT OF THROMBOPHLEBITIS. ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF QA RESULTS ON (B)(4) 2010. 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 OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 29-JUL-2010 FROM A HEALTHCARE PROVIDER (HCP). MEDICAL HISTORY WAS UPDATED TO INCLUDE GRAVIDIC NEPHROPATHY, PSORIASIS, CHOLECYSTECTOMY, BILATERAL OVARIECTOMY, TWO ARTHROSCOPIC MENISECTOMIES AND DEGENERATIVE GONARTHRITIS. THE CURRENT SERIES OF SYNVISC WAS ADMINISTERED ON (B)(6) 2010. THE KNEE WAS "PUNCTURED" PRIOR TO SYNVISC INJECTION. SYNVISC WAS AT ROOM TEMPERATURE WHEN ADMINISTERED WITH AT 21 GAUGE NEEDLE. FOLLOWING THE FIRST INJECTION IN THE RIGHT KNEE, THE PATIENT EXPERIENCED KNEE PAIN THAT RESOLVED WITHIN FOUR DAYS. ON (B)(6) 2010, THE PATIENT EXPERIENCED LEFT KNEE SWELLING, CALF SWELLING, AND FEVER. ON (B)(6) 2010, ULTRASOUND EXAMINATION WAS PERFORMED. THE DIAGNOSIS WAS LEFT BAKER CYST RUPTURE. THE HCP INDICATED THAT HE COULD NOT CONFIRM THE EVENT OF THROMBO-PHLEBITIS. SYNOVIAL FLUID ANALYSIS FROM JOINT PUNCTURE ON (B)(6) 2010 REVEALED :CITRINE/INFLAMMATORY FLUID, RED BLOOD CELL COUNT 4800/ MM3, WHITE BLOOD CELL COUNT 8250/MM3, 40% NEUTROPHILS, 60% MONOCYTES. THE HCP REPORTED THAT THE EVENTS OF RIGHT KNEE EFFUSION, LEFT BAKER CYST RUPTURE, AND FEVER WERE SEVERE AND DEFINITELY RELATED TO SYNVISC. THE PATIENT RECOVERED FROM THE EVENTS ON (B)(6) 2010. ADDITIONAL INFORMATION WAS RECEIVED IN THE FORM OF QA RESULTS ON 03-AUG-2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER P10072, EXPIRATION DATE 01/2013 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    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 P10072

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other