BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2213983 · Received August 4, 2011

    Report

    Report Number
    2246315-2011-00193
    Event Type
    Other
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 IN THE FORM OF AN INVESTIGATION SUMMARY. 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. 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 THE REPORT.

    Description of Event or Problem · 1

    ARTHRITIS OF RIGHT KNEE [ARTHRITIS]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS T-T, WITH GONARTHROSIS. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR GASTRITIS. ON (B)(6) 2011, THE PT INITIATED SYNVISC 2 ML 1X/WEEK INTO BOTH KNEES. ON (B)(6) 2011, THE PT RECEIVED THE SECOND INJECTION OF SYNVISC INTO BOTH KNEES. ON (B)(6) 2011, THE PT RECEIVED THE THIRD INJECTION OF SYNVISC INTO THE RIGHT KNEE ONLY. ON THE SAME DATE, THE PT EXPERIENCED KNEE PAIN AND SWELLING. ON (B)(6) 2011, 40CC OF SYNOVIAL FLUID WERE ASPIRATED FROM THE RIGHT KNEE. THE SWELLING AND PAIN STARTED TO IMPROVE. THE PHYSICIAN DIAGNOSED THE EVENTS AS PSEUDOGOUT OF THE RIGHT KNEE. ON (B)(6) 2011, SYNVISC WAS PERMANENTLY DISCONTINUED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE: DICLOFENAC SODIUM 25MG 3X/DAY FOR GONARTHROSIS FROM (B)(6) 2011 AND CONTINUING; TEPRENONE 50MG 3X/DAY FOR GASTRITIS FROM (B)(6) 2011 AND CONTINUING; AND FLURBIPROFEN 20MG 2X/DAY FOR GONARTHROSIS FROM (B)(6) 2011 AND CONTINUING. THE INTENSITY FOR THE EVENT OF PSEUDOGOUT OF RIGHT KNEE WAS NOT ASSESSED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF PSEUDOGOUT OF RIGHT KNEE AS DEFINITELY RELATED. THE PT'S OUTCOME FOR THE EVENT OF PSEUDOGOUT OF RIGHT KNEE WAS REPORTED AS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011 FROM THE PHYSICIAN. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS TREATMENT WITH SODIUM HYALURONATE AND METHYLPREDNISOLONE ACETATE ON (B)(4) 2011 FOR GONARTHROSIS. THE DATE OF THE THIRD SYNVISC INJECTION WAS CHANGED TO (B)(6) 2011. ON (B)(6) 2011, PRIOR TO THE INJECTION, 25CC OF SYNOVIAL FLUID WERE ASPIRATED FROM THE RIGHT KNEE. THE FLUID WAS YELLOW AND TRANSPARENT, RULING OUT ARTHRITIS. AFTER THE INJECTION, PAIN AND SWELLING DEVELOPED IN THE RIGHT KNEE. ON AN UNSPECIFIED DATE IN (B)(6) 2011, THE PT RETURNED TO THE CLINIC AND 47 ML OF YELLOW, OPAQUE JOINT FLUID WERE ASPIRATED. THE FLUID CULTURE WAS NEGATIVE FOR BACTERIA. LAB TESTS PERFORMED ON (B)(6) 2011 SHOWED THE FOLLOWING RESULTS WHICH WERE ABOVE THE INSTITUTION'S NORMAL RANGE: WBC AT 10,800/MM3; ANTI-CCP ANTIBODY AT 0.6; AND ANTI-GALACTOSE DEFICIENCY IGG ANTIBODY AT 8. IN ADDITION TO THE KNEE ASPIRATION, THE PT RECEIVED AN INJECTION OF 20MG OF METHYLPREDNISOLONE ACETATE INTO THE KNEE AS TREATMENT. THE PHYSICIAN DIAGNOSED THE EVENT AS ARTHRITIS OF THE RIGHT KNEE (CHANGED FROM PSEUDOGOUT), AND FELT THAT THE EVENT WAS AN IMMUNE REACTION AGAINST SYNVISC. ON (B)(6) 2011, SYNVISC WAS PERMANENTLY DISCONTINUED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE VOLTAREN SR (DICLOFENAC SODIUM) 37.5MG CAPSULE TAKEN ORALLY FROM (B)(6) 2011 TO (B)(6) 2011 FOR GONARTHROSIS; VOLTAREN (DICLOFENAC SODIUM) 25MG 3X/DAY TABLET TAKEN ORALLY FROM (B)(6) 2011 TO (B)(6) 2011; AND THE DOSES FOR TEPRENONE AND FLURBIPROFEN MENTIONED PREVIOUSLY. THE INTENSITY FOR THE EVENT OF ARTHRITIS OF RIGHT KNEE WAS NOT ASSESSED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF ARTHRITIS OF RIGHT KNEE AS DEFINITELY RELATED. THE PT'S OUTCOME FOR THE EVENT OF ARTHRITIS OF RIGHT KNEE WAS REPORTED AS NOT YET RECOVERED.

    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 52 YR Required Intervention VOLTAREN (DICLOFENAC SODIUM)| TEPRENONE (TEPRENONE)| TABLET| FLURBIPROFEN (FLURBIPROFEN)| VOLTAREN SR (DICLOFENAC SODIUM)| CAPSULE