BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2222542 · Received August 11, 2011

    Report

    Report Number
    2246315-2011-00196
    Event Type
    Other
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 1, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION 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

    SYNOVITIS IN THE LEFT KNEE/SEVERE INFLAMMATION [SYNOVITIS]. JOINT EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2011, FROM A PHYSICIAN REGARDING A (B)(6) MALE PT, INITIALS (B)(6) WHO EXPERIENCED SYNOVITIS IN THE LEFT KNEE AND JOINT EFFUSION AFTER STARTING SYNVISC-ONE. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR MODERATE OSTEOARTHRITIS (X-RAY GRADE: III-IV), PRIOR JOINT EFFUSION, JOINT NARROWING AND OSTEOPHYTES. ON (B)(6) 2011, THE PT RECEIVED AN INJECTION OF SYNVISC-ONE IN HIS LEFT KNEE. THE PHYSICIAN REPORTED THAT THERE WERE NO RISK FACTORS PRIOR TO THE INJECTION WHICH MAY HAVE CONTRIBUTED TO THE ADVERSE EVENTS EXPERIENCED SUBSEQUENTLY. ON (B)(6) 2011, THE PT EXPERIENCED SYNOVITIS IN HIS LEFT KNEE AND SEVERE INFLAMMATION. ON (B)(6) 2011, ARTHROCENTESIS WAS PERFORMED AND 100 CC OF SYNOVIAL FLUID WAS DRAINED FROM THE PT'S LEFT KNEE. ON (B)(6) 2011, ARTHROCENTESIS WAS PERFORMED AGAIN AND 50 CC OF SYNOVIAL FLUID WAS DRAINED FROM THE PT'S LEFT KNEE. ON (B)(6) 2011, AN INJECTION OF DEXAMETHASONE WAS ADMINISTERED TO TREAT THE PT'S LEFT KNEE SYNOVITIS. THE PHYSICIAN REPORTED THAT THE EVENTS WERE SEVERE AND DEFINITELY RELATED TO SYNVISC-ONE. THE PRODUCT LOT NUMBER WAS NOT PROVIDED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS RECOVERED. ADDITIONAL INFO WAS RECEIVED ON (B)(4) 2011, IN THE FORM OF QA RESULTS. 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 SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION 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.

    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 60 YR Required Intervention