BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1141351 · Received August 28, 2008

    Report

    Report Number
    2246315-2008-00125
    Event Type
    Other
    Date Received
    August 28, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 21, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 SYNOVITIS (GRANULOMATOUS) [SYNOVITIS]. CASE DESCRIPTION; SPONTANEOUS REPORT RECEIVED ON (B) (6) 2008 FROM THE PHYSICIAN REGARDING A (B) (6) MALE PATIENT WITH MEDICAL HISTORY OF ARTHROSIS, INITIAL (B) (6). THE PATIENT RECEIVED THREE INTRA-ARTICULAR INJECTIONS OF SYNVISC, STARTING ON (B) (6) 2008, ADMINISTERED ONE WEEK APART. SYNVISC WAS LAST ADMINISTERED PRIOR TO THE REPORTED EVENT ON (B) (6) 2008. ON (B) (6) 2008, THE PATIENT EXPERIENCED GRANULOMATOUS SYNOVITIS OF THE RIGHT KNEE DESCRIBED AS REDNESS, PAIN AND WARMTH WHICH DEVELOPED IN 2-3 DAYS. THE C-REACTIVE PROTEIN (CRP) ROSE FROM 18 TO 42 IN 24 HOURS. THE PATIENT WAS AFEBRILE. IN (B) (6) (ON AN UNSPECIFIED DATE) AN ARTICULAR PUNCTURE WAS DONE, THE ASPIRATE WAS NOT CLEAR WITH 6500 WHITE BLOOD CELLS/MICROLITRE. THE CULTURE WAS STERILE FOR GRAM NEGATIVE GEMS IN 48 HOURS. PRIOR CLINICAL ASSESSMENT OF INFECTION AND BIOLOGY, ARTHROSCOPY WAS DONE WITH DRAINAGE IN AN EMERGENCY DEPARTMENT AND TREATMENT WITH INTRAVENOUS VANCOMYCINE AND FLOXAPEN. GOOD CLINICAL EVOLUTION AND LOWERING OF CRP BUT STILL 15 ON THE (B) (6) 2008. THE PHYSICIAN ASSESSED THE SEVERITY OF THE EVENT AS MODERATE. TREATMENT WITH SYNVISC WAS PERMANENTLY STOPPED. THE ASSESSMENT OF THE PHYSICIAN REGARDING THE RELATIONSHIP BETWEEN THE EVENT AND SYNVISC WAS PENDING. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PATIENT OUTCOME WAS NOT YET RECOVERED. INVESTIGATION RESULT RECEIVED ON (B) (6) 2008: 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 SPECIFICATIONS CONFORMANCE PRIOR TO RELEASE. ANY 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 VISCOSUPPLEMENT MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention