BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2214093 · Received July 20, 2011

    Report

    Report Number
    2246315-2011-00181
    Event Type
    Other
    Date Received
    July 20, 2011
    Date of Event
    April 1, 2011
    Report Date
    July 11, 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

    MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. 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

    RIGHT KNEE STARTED TO BE PAINFUL [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A (B)(6) MALE PT, INITIALS (B)(6), WHO EXPERIENCED KNEE PAIN AFTER RECEIVING SYNVISC. THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR OSTEOARTHRITIS IN BOTH KNEES. IN (B)(6) 2011, THE PT RECEIVED A SERIES OF THREE SYNVISC INJECTIONS IN EACH KNEE (EXACT DATES NOT PROVIDED). THE PT REPORTED THAT ONE WEEK FOLLOWING THE FINAL INJECTION, THE PT EXPERIENCED RIGHT KNEE PAIN (EXACT DATE NOT PROVIDED). IN (B)(6) 2011, THE PT'S KNEE PAIN WAS TREATED WITH A CORTISONE SHOT IN THE RIGHT KNEE (EXACT DATE NOT PROVIDED). OTHER TREATMENT HAS INCLUDED TRAMADOL. THE PRODUCT LOT NUMBER WAS NOT REPORTED. AT THE TIME OF THIS REPORT THE OUTCOME OF THE PT WAS NOT YET 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 (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention