BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2163620 · Received June 8, 2011

    Report

    Report Number
    2246315-2011-00134
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: ON (B)(6) 2011, ADD'L INFO WAS RECEIVED IN THE FORM OF QA RESULTS WITHOUT A LOT NUMBER. 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 RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    Description of Event or Problem · 1

    HAS A LIMP [GAIT DISTURBANCE]. KNEE HAS BEEN SWOLLEN [JOINT SWELLING]. WORSENING KNEE PAIN [ARTHRALGIA]. FLUID WAS DRAINED FROM THE KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A CONSUMER REGARDING A (B)(6) MALE PT, INITIALS (B)(6), WITH OSTEOARTHRITIS. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR PREVIOUS TREATMENT WITH SYNVISC-ONE, FIVE MONTHS PRIOR TO THE REPORT. ON AN UNSPECIFIED DATE, APPROX ONE MONTH PRIOR TO THE REPORT, THE PT INITIATED SYNVISC-ONE 6 ML ONCE IN THE RIGHT KNEE. ON AN UNSPECIFIED DATE, THE PT EXPERIENCED KNEE SWELLING AND WORSENING KNEE PAIN. THE PT ALSO HAD A LIMP AND HAD TO WALK WITH A WALKER. THE EVENTS REQUIRED TREATMENT WITH ADVIL, TYLENOL, MOTRIN PM, HYDROCODONE/APAP 5MG/500MG, AND ICE. ON (B)(6) 2011, FLUID WAS DRAINED FROM THE KNEE AND NO INFECTION WAS PRESENT. ON (B)(6) 2011, THE PT RECEIVED A CORTISONE INJECTION. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS NOT PROVIDED. AT THE TIME OF THIS REPORT, THE PT HAD NOT YET RECOVERED FROM THE EVENTS.

    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 74 YR Required Intervention