BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2845017 · Received November 8, 2012

    Report

    Report Number
    2246315-2012-00346
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    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

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    REDNESS IN RIGHT KNEE [ERYTHEMA]. HOT FEELING IN RIGHT KNEE [JOINT WARMTH]. RIGHT KNEE PAIN [ARTHRALGIA]. RIGHT KNEE SWELLING [JOINT SWELLING]. RIGHT KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A PHYSICIAN REGARDING A (B)(6), WITH GONARTHROSIS OF RIGHT KNEE. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC (FIRST COURSE, THREE INJECTIONS FROM (B)(6) 2011). ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20), ROUTE AND DOSAGE REGIMEN NOT PROVIDED, IN RIGHT KNEE. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT DEVELOPED ARTHRITIS. ON (B)(6) 2012, THE PATIENT RECOVERED FROM THE EVENT OF ARTHRITIS. CONCOMITANT MEDICATION WAS NOT PROVIDED. THE INTENSITY FOR THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT AS DEFINITE. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2012, FROM A PHYSICIAN PROVIDING PATIENT'S MEDICAL HISTORY, SUSPECT THERAPY DETAILS, LABORATORY TESTS, EVENTS INFORMATION AND TREATMENT MEDICATION. THE CASE WAS UPGRADED TO SERIOUS, AS THE PATIENT REQUIRED INTERVENTION. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR RIGHT KNEE PAIN. ON (B)(6) 2012, THE PATIENT RECEIVED FIRST INTRA-ARTICULAR SYNVISC INJECTION (SECOND COURSE), AT A DOSE OF 2 ML, ONCE WEEKLY AND THE SAME DAY TREATMENT WITH SYNVISC WAS PERMANENTLY DISCONTINUED. THE LOT NUMBER FOR SYNVISC WAS UNKNOWN TO THE REPORTER. IT WAS REPORTED THAT THE PATIENT HAD NO COMPLICATIONS INDUCING IMMUNE SYSTEM DECREASED, GENERALIZED INFECTIOUS SYMPTOMS, OR FLUID RETENTION PRIOR TO THE INJECTION. THE EVENT TERM ARTHRITIS WAS UPDATED TO RIGHT KNEE PAIN AND RIGHT KNEE SWELLING. ON (B)(6) 2012, THE PATIENT EXPERIENCED RIGHT KNEE PAIN, RIGHT KNEE SWELLING WITH HOT FEELING AND REDNESS, INDICATING MILD INFLAMMATORY SYMPTOM. ON THE SAME DAY, ARTHROCENTESIS WAS PERFORMED AND 0.5 ML OF FLUID WAS ASPIRATED FROM THE RIGHT KNEE. IT WAS REPORTED THAT THE SYNOVIAL FLUID ANALYSIS, FLUID CULTURE AND SMEAR TEST RESULTS WERE NEGATIVE. THE PATIENT WAS GIVEN TREATMENT WITH TRIAMCINOLONE FOR RIGHT KNEE PAIN AND SWELLING. THE OUTCOME FOR THE EVENTS OF RIGHT KNEE EFFUSION, HOT FEELING AND REDNESS IN RIGHT KNEE WAS NOT PROVIDED. THE INTENSITY FOR THE EVENTS OF RIGHT KNEE PAIN AND SWELLING WAS MODERATE. THE INTENSITY FOR THE EVENT OF RIGHT KNEE EFFUSION, HOT FEELING AND REDNESS IN RIGHT KNEE WAS NOT PROVIDED. IT WAS REPORTED THAT THE SYNVISC WAS A DEFINITE SUSPECT DRUG AS THE PATIENT'S ARTHRALGIA AGGRAVATED IMMEDIATELY AFTER THE FIRST SYNVISC INJECTION OF SECOND COURSE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF RIGHT KNEE PAIN AND SWELLING AS DEFINITE AND DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF RIGHT KNEE EFFUSION, HOT FEELING AND REDNESS ON RIGHT KNEE.

    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 74 YR Required Intervention