BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTIOJN

    MDR report key: 3240821 · Received July 18, 2013

    Report

    Report Number
    2246315-2013-00402
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: F/U INFO WAS RECEIVED ON (B)(4) 2013 IN THE FORM OF QA (QUALITY ASSURANCE) SUMMARY. THE PRODUCT AND QUALITY CONTROL DOCUMENTATION FOR LOT #U1204, WITH EXPIRATION DATE (07/2015) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC ONE IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    DECREASED RANGE OF MOTION [JOINT RANGE OF MOTION DECREASED], SWELLING [SWELLING], WHITE BLOOD CELL COUNT IN SYNOVIAL FLUID [SYNOVIAL FLUID WHITE BLOOD CELLS POSITIVE], INJECTION SITE WARMTH [INJECTION SITE WARMTH], KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6) WITH OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, THE PT INITIATED TREATMENT WITH BILATERAL SYNVISC-ON (HYLAN GF-20) INJECTION AT A DOSE OF 06 ML ONCE (ROUTE OF ADMINISTRATION). ON UNSPECIFIED DATES, THE PT DEVELOPED INJECTION SITE WARMTH, SWELLING AND DECREASED RANGE OF MOTION. IT WAS REPORTED THAT THE AREA WAS NOT RED OR WARM TO TOUCH. THE OUTCOME FOR ALL THE EVENTS WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP OF SYNVISC-ONE WITH ALL THE EVENTS. F/U INFO WAS RECEIVED ON (B)(6) 2013 FROM THE PHYSICIAN REGARDING PT'S MEDICAL HISTORY, PRODUCT, EVENT AND TREATMENT INFO WHICH UPGRADED THE CASE TO SERIOUS (AS THE PT UNDERWENT RIGHT KNEE ARTHROPLASTY). PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SEVERE OSTEOARTHRITIS OF BOTH KNEES AND PREVIOUS USE OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS AND VISCO-SUPPLEMENTATION WITH AN UNK PRODUCT. IT WAS REPORTED THAT THE PT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC-ONE ON (B)(6) 2013. ON (B)(6) 2013, THE PT DEVELOPED INJECTION SITE WARMTH, SWELLING AND DECREASED RANGE OF MOTION. ON (B)(6) 2013, 65 CC OF KNEE JOINT FLUID WAS ASPIRATED FOR THE TREATMENT OF SWELLING. SYNOVIAL ANALYSIS WAS PERFORMED WHICH SEEMED TO BE INFLAMMATORY WITH THE PRESENCE OF MODERATE WHITE BLOOD CELLS (WBC), NEUTROPHILS, MONOCYTES, LYMPHOCYTES, MACROPHAGES AND EOSINOPHILS, SHOWED SOME YELLOW HAZINESS AND A FEW RED BLOOD CELLS. ALSO VISCOSITY WAS DECREASED. ON THE SAME DAY, THE PT RECOVERED FROM THE EVENTS OF INJECTION SITE WARMTH, SWELLING AND DECREASED RANGE OF MOTION ON (B)(6) 2013, THE PT UNDERWENT TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR THE DECREASED RANGE OF MOTION. THE OUTCOME FOR THE EVENTS OF KNEE EFFUSION AND WHITE BLOOD CELL COUNT IN SYNOVIAL FLUID WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDIATIONS INCLUDE MOBIC (MILOXICAM) AND VOLTAREN (DICLOFENAC). THE INTENSITY FOR THE EVENTS OF INJECTION SITE WARMTH, SWELLING AND DECREASED RANGE OF MOTION WAS SEVERE. THE INTENSITY FOR THE EVENTS OF KNEE EFFUSION AND WHITE BLOOD CELL COUNT IN SYNOVIAL FLUID WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP OF SYNVISC-ONE WITH THE EVENTS OF INJECTION SITE WARMTH, SWELLING AND DECREASED RANGE OF MOTION AS DEFINITE. HOWEVER, THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP OF SYNVISC-ONE WITH THE EVENTS OF KNEE EFFUSION AND WHITE BLOOD CELL COUNT IN SYNOVIAL FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336365 SYNVISC ONE (HYLAN G-F 20) INJECTIOJN INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK U1204

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention