BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION 2ML

    MDR report key: 1285908 · Received November 13, 2008

    Report

    Report Number
    2246315-2008-00163
    Date Received
    November 13, 2008
    Report Date
    November 6, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NIT PROVIDED AND 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. ON A PERIODIC BASIS, DATA IS PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED TO ANY PRODUCT COMPLAINT. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR COMPLAINTS AS STATED IN SOP USQA1048 AEOE PRODUCT COMPLAINT HANDLING TO DETERMINE IF CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    KNEE PROSTHESIS PLACEMENT [KNEE ARTHROPLASTY]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 06-NOV-2008 FROM A PHYSICIAN REGARDING A (B) (6) FEMALE PT WITH GONARTHROSIS, INITIALS UNK. THE MEDICAL HISTORY OF THE PT INCLUDED DRUG INDUCED FLUSH WITH ALTIM (CORTIVAZOL) AND TENDONITIS OF THE GLUTEUS MEDIUS MUSCLE. THE PT RECEIVED SYNVISC TREATMENT IN 2007 AND ON AN UNDETERMINED DATE FOLLOWING THE TREATMENT, THE PT UNDERWENT KNEE PROSTHESIS PLACEMENT. NO FURTHER INFO WAS AVAILABLE REGARDING THE OUTCOME OR CAUSALITY. FOR OTHER EVENTS EXPERIENCED BY THIS PT, (B) (4). INVESTIGATION SUMMARY RECEIVED ON 12-NOV-2008: THE PRODUCT LOT NUMBER WAS NOT PROVIDED AND 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. ON A PERIODIC BASIS, DATA IS PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED TO ANY PRODUCT COMPLAINT. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR COMPLAINTS AS STATED IN SOP USQA1048 ACEO PRODUCT COMPLAINT HANDLING AC TO DETERMINE IF CORRECTIVE ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION 2ML VISCOSUPPLEMENT MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R