BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1833869 · Received September 8, 2010

    Report

    Report Number
    2246315-2010-00178
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC-ONE IS NOT AFFECTED BY THIS REPORT. EVAL 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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSABLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

    Description of Event or Problem · 1

    STIFFNESS IN THE LEFT KNEE (JOINT STIFFNESS), SWELLING IN THE LEFT KNEE (JOINT SWELLING), PAIN IN THE LEFT KNEE (ARTHRALGIA), LEFT KNEE EFFUSION (JOINT EFFUSION). CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS (B)(6). THE PT HAD A HISTORY OF OSTEOARTHRITIS OF THE LEFT KNEE AND PREVIOUS SYNVISC ONE TREATMENT IN (B)(6) 2010. THE PT RECEIVED A SYNVISC ONE INJECTION IN THE LEFT KNEE ON (B)(6) 2010. APPROX 6 HOURS AFTER THE INJECTION THE PT BEGAN TO EXPERIENCE PAIN, SWELLING, AND STIFFNESS IN THE LEFT KNEE. THE SYMPTOMS HAD BECOME PROGRESSIVELY WORSE. ON (B)(6) 2010, THE PT WAS SEEN BY THE PHYSICIAN AND 60 CC OF FLUID WAS DRAINED FROM THE LEFT KNEE AND THE PT WAS GIVEN A CORTICOSTEROID INJECTION IN THE LEFT KNEE. THE PHYSICIAN ASSESSED THE EVENTS AS DEFINITELY RELATED TO SYNVISC ONE. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT HAD NOT YET RECOVERED. SEE (B)(4) FOR ANOTHER ADVERSE EVENT CASE FROM THIS REPORTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention