BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3191007 · Received June 24, 2013

    Report

    Report Number
    2246315-2013-00371
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER U1212A, EXPIRY DATE 2015-07 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NONCONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    KNEE STIFFNESS [JOINT STIFFNESS], KNEE SWELLING [JOINT SWELLING], KNEE PAIN [ARTHRALGIA], KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6), WITH OSTEOARTHRITIS AND FIBROMYALGIA. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS TREATMENT WITH SYNVISC (HYLAN G-F 20) (IN (B)(6) 2012) WITH NO PROBLEMS. ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION IN AN UNSPECIFIED KNEE (DOSAGE REGIMEN AND ROUTE OF ADMINISTRATION NOT PROVIDED). ON (B)(6) 2013, THE PATIENT RECEIVED TREATMENT WITH THE SECOND SYNVISC INJECTION. ON THE SAME DAY, 02 HOURS AFTER GETTING HOME, THE PATIENT DEVELOPED KNEE STIFFNESS, KNEE SWELLING AND KNEE PAIN. THE PATIENT ICED THE KNEE AND RECEIVED TREATMENT TYLENOL (PARACETAMOL) FOR THE EVENTS OF KNEE STIFFNESS, KNEE SWELLING AND KNEE PAIN. ON (B)(6) 2013, THE PATIENT CAME BACK TO THE PHYSICIAN'S OFFICE AS A WALK IN AND 2 CC OF JOINT FLUID WAS ASPIRATED FROM THE KNEE (KNEE EFFUSION). THE JOINT FLUID WAS SENT FOR CULTURE AND THE PATIENT RECEIVED TREATMENT WITH DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION AND PREDNISOLONE FOR THE EVENTS OF KNEE STIFFNESS, KNEE SWELLING, KNEE EFFUSION AND KNEE PAIN. IT WAS REPORTED THAT THE PATIENT WAS FINE THE NEXT DAY. ON (B)(6) 2013, THE PATIENT'S SYNOVIAL FLUID CULTURE WAS NEGATIVE FOR AN INFECTION. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF KNEE PAIN, KNEE STIFFNESS, KNEE SWELLING AND KNEE EFFUSION WAS NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE REPORTING PHYSICIAN DID NOT PROVIDE THE RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285624 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK U1212A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention