BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2483173 · Received March 2, 2012

    Report

    Report Number
    2246315-2012-00047
    Event Type
    Other
    Date Received
    March 2, 2012
    Date of Event
    January 1, 2012
    Report Date
    February 23, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QA) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2012. 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 RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAD NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    PROLIFIC SYNOVITIC REACTION [SYNOVITIS], SEVERE SWELLING (KNEE) [JOINT SWELLING], 180 ML OF STRAW-COLORED FLUID DRAINED FROM THE KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012 FROM AN ORTHOPEDIST REGARDING A (B)(6) FEMALE PT, INITIAL (B)(6). THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR ARTHROSCOPY AND MINIMAL DEGENERATIVE CHANGES ON THE KNEE. ON (B)(6) 2012, THE PT INITIATED SYNVISC (HYLAN G-F 20) INJECTION OF 2 ML ONCE WEEKLY IN AN UNSPECIFIED KNEE. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. IT WAS REPORTED THAT SYNVISC WAS INJECTED UNDER DIRECT ARTHROSCOPIC VISION INTO THE KNEE JOINT. ON AN UNK DATE, THE PT DEVELOPED SEVERE SWELLING AND A WEEK LATER HAD 180 ML OF STRAW-COLORED FLUID DRAINED FROM THE KNEE. THE WHITE CELL COUNT WAS NORMAL AND THERE WAS NO INFECTION. IT WAS REPORTED THAT THE PT "DID NOT SETTLE" AND THE REPORTING PHYSICIAN PERFORMED AN ARTHROSCOPIC SYNOVECTOMY AND AGAIN THERE WAS A PROLIFIC SYNOVITIC REACTION. THE EVENT OF PROLIFIC SYNOVITIC REACTION WAS MEDICALLY SIGNIFICANT. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME OF ALL THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITIES FOR THE EVENTS OF 180 ML OF STRAW-COLORED FLUID DRAINED FROM THE KNEE AND PROLIFIC SYNOVITIC REACTION WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND ALL THE EVENTS WAS NOT PROVIDED.

    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 46 YR Other| R