BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1853243 · Received September 30, 2010

    Report

    Report Number
    2246315-2010-00200
    Event Type
    Other
    Date Received
    September 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 18, 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

    EVALUATION 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.

    Description of Event or Problem · 1

    BILATERAL LEG CRAMPS [MUSCLE SPASMS]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN REGARDING A (B)(6) OLD FEMALE PT, INITIALS (B)(6). THE PT HAD A HISTORY OF OSTEOARTHRITIS OF BOTH KNEES. THE PT RECEIVED A SYNVISC INJECTION IN EACH KNEE ON (B)(6) 2010. THE PT COMPLAINED OF BILATERAL LEG CRAMPS WHICH LASTED FOR ABOUT ONE WEEK. THE PHYSICIAN ASSESSED THE EVENT AS PROBABLY RELATED TO SYNVISC. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT HAD RECOVERED. ADDITIONAL INFO WAS RECEIVED FROM THE PHYSICIAN ON (B)(6) 2010 AND (B)(6) 2010. THE PT HAD A HISTORY OF MODERATE OSTEOARTHRITIS FOR MAY YEARS. THE PT ALSO HAD A HISTORY OF JOINT NARROWING AND OSTEOPHYTES. THE PT HAD NO HISTORY OF PRIOR KNEE EFFUSION. THE PT WAS PREVIOUSLY TREATED WITH NSAIDS. THE PHYSICIAN REPORTED THAT THE TREATMENT FOR THE BILATERAL LEG CRAMPS WAS IV STEROIDS WITH THE SECOND AND THIRD SYNVISC INJECTIONS WHICH WERE ADMINISTERED IN BOTH KNEES ON (B)(6) 2010 AND (B)(6) 2010. THE PHYSICIAN WAS UNABLE TO PROVIDE THE LOT NUMBER OF SYNVISC USED. THE PHYSICIAN ASSESSED THE BILATERAL LEG CRAMPS AS SEVERE AND POSSIBLY RELATED TO SYNVISC. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT HAD RECOVERED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010 IN THE FORM OF A QA INVESTIGATION 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.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention