BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2093611 · Received April 19, 2011

    Report

    Report Number
    2246315-2011-00082
    Event Type
    Other
    Date Received
    April 19, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 23, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT #R1006, WITH EXPIRATION DATE (03/2013) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # N1006, WITH EXPIRATION DATE (01/2013) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    DISCOMFORT [MUSCULOSKELETAL DISCOMFORT]. LOST CONTROL OF KNEES AND DROPPED [JOINT INSTABILITY]. NOT ABLE TO FLEX KNEES PROPERLY [JOINT RANGE OF MOTION DECREASED]. DIFFICULTY WALKING [GAIT DISTURBANCE]. PAIN DURING INJECTION [INJECTION SITE PAIN]. INFLAMMATION [ARTHRITIS]. PAIN IN THE KNEES [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6)-2011 FROM A (B)(6) FEMALE PATIENT, (B)(6), WITH ARTHRITIS. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6)-2011, THE PATIENT INITIATED SYNVISC 2ML 1X/WEEK IN EACH KNEE. THE REPORTED LOT NUMBERS USED WERE N10068 WITH EXPIRATION DATE JAN 2013, AND R1006 WITH EXPIRATION DATE MAR 2013. THE PATIENT HAD PAIN DURING THE INJECTIONS AND SEVERE PAIN FOR ONE WEEK FOLLOWING THE FIRST INJECTION. ON (B)(6)-2011, THE SECOND INJECTION WAS ADMINISTERED WITHOUT SYMPTOMS. ON (B)(6)-2011, THE THIRD INJECTION WAS ADMINISTERED AND THE PATIENT EXPERIENCED PAIN IN THE KNEES, DIFFICULTY WALKING, AND INABILITY TO FLEX THE KNEES PROPERLY. NO ACTION WAS TAKEN REGARDING THE GENZYME PRODUCT. THE PATIENT'S OUTCOME FOR THESE EVENTS WAS REPORTED AS NOT YET RECOVERED. RELEVANT CONCOMITANT MEDICATION REPORTED INCLUDES TARIFOL AC (DICLOFENAC, PARACETAMOL), INDICATED FOR ARTHRITIS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)-2011 IN THE FORM OF AN INVESTIGATION SUMMARY. THE PRODUCT AND QUALITY CONTROL DOCUMENTATION FOR LOT #R1006, WITH EXPIRATION DATE (03/2013) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# N1006, WITH EXPIRATION DATE (01/2013) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)-2011 FROM THE PATIENT. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR RHEUMATOID ARTHRITIS. THE DATES OF SYNVISC 2ML 1X/WEEK IN EACH KNEE. ON (B)(6)-2011, THE SECOND INJECTION WAS ADMINISTERED, AND ON (B)(6)-2011, THE THIRD INJECTION WAS ADMINISTERED. ON (B)(6)-2011, THE PATIENT PRESENTED WITH DISCOMFORT AND HER PHYSICIAN RECOMMENDED THE USE OF (B)(4), MELOXICAM, AND HOT COMPRESSES. THE DISCOMFORT IMPROVED BUT RETURNED ON (B)(6)-2011. THE PATIENT EXPERIENCED PAIN AND INFLAMMATION. THE PAIN BECAME MORE INTENSE UPON STANDING AND WALKING, AND THE PATIENT REQUIRED HELP TO STAND. THE PAIN INTERFERED WITH ACTIVITIES AND SOMETIMES WOULD RESULT IN THE PATIENT LOSING CONTROL OF HER KNEES AND DROPPING. ON (B)(6)-2011, THE PHYSICIAN PRESCRIBED (B)(4) FOR TREATMENT OF THE EVENTS. AS OF (B)(6)-2011, THE PATIENT'S OUTCOME FOR THESE EVENTS WAS STILL 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 N10068, R1006

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention