BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1961000 · Received January 11, 2011

    Report

    Report Number
    2246315-2011-00006
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    January 5, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. 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

    INCREASED PAIN IN KNEE [ARTHRALGIA]. KNEE WAS ASPIRATED [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM A HEALTH CARE PROVIDER, VIA A COMPANY REPRESENTATIVE, REGARDING A FEMALE PT (UNK AGE AND INITIALS)., THE PT HAD A HISTORY OF OSTEOARTHRITIS OF THE KNEE. THE PT EXPERIENCED INCREASED PAIN IN HER KNEE AND HAD HER KNEE ASPIRATED AFTER RECEIVING SYNVISC-ONE. ON AN UNSPECIFIED DATE, IN LATE (B)(6) 2010, THE PT RECEIVED A SYNVISC-ONE INJECTION IN AN UNSPECIFIED KNEE. ON (B)(6) 2011, THE HEALTH CARE PROVIDER REPORTED THE PT HAD INCREASED PAIN IN HER KNEE AFTER THE SYNVISC-ONE INJECTION. THE KNEE WAS ASPIRATED AND A CULTURE WAS DONE WHICH WAS NEGATIVE. THE PT WAS HOSPITALIZED. NO OTHER INFO WAS PROVIDED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PT WAS UNK. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 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 CONFORMANCE TO SPECIFICATIONS PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATE 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. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    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 UNK Hospitalization