BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAND G-F 20) INJECTION

    MDR report key: 3096076 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00127
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    April 5, 2001
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2013. 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. MANUFACTURER'S COMMENT: THIS CASE REPORT BELONGS TO A BATCH OF ICSRS FROM A DATABASE EXTRACTION CONTAINING A COLLECTION OF DATA FROM 10/1997 TO 07/2010. THE BENEFIT RISK PROFILE OF THE PRODUCT IS NOT ALTERED BY THIS REPORT.

    Description of Event or Problem · 1

    SYNOVITIS [SYNOVITIS]. BILATERAL KNEE EFFUSION [JOINT EFFUSION]. TOTAL KNEE REPLACEMENT IN BOTH KNEES [KNEE ARTHROPLASTY]. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A FEMALE PT (AGE NOT PROVIDED), INITIAL UNK WITH OSTEOARTHRITIS (KELLGREN AND LAWRENCE GRADE 4). THIS CASE BELONGS TO A BATCH OF ICSRS FROM A COMPANY PURCHASED DATABASE CONTAINING A COLLECTION OF DATA FROM (B)(6) 1997 TO (B)(6) 2010. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC OF FIRST AND SECOND COURSE AND SYNOVITIS. IT WAS REPORTED THAT THE PT'S AGE WAS REPORTED TO BE (B)(6) AT THE TIME OF 1ST COURSE OF SYNVISC INJECTION. ON (B)(6) 2001, THE PT INITIATED TREATMENT WITH FIRST INTRA-ARTICULAR SYNVISC (HYLAN G-F 20) INJECTION IN BOTH KNEES, DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2001, THE PT EXPERIENCED SYNOVITIS IN BOTH KNEES. ON AN UNSPECIFIED DATE IN (B)(6) 2011, ARTHROCENTESIS WAS PERFORMED WHERE 25 CC OF JOINT FLUID WAS ASPIRATED FROM BOTH THE KNEES. THE PT WAS TREATED WITH INTRA-ATICULAR CELESTONE AND INTRA-ARTICULAR XYLOCAINE FOR THE EVENTS OF SYNOVITIS IN BOTH KNEES AND BILATERAL KNEE EFFUSION. THE ACTION TAKEN WITH SYNVISC WAS NOT PROVIDED. ON (B)(6) 2001, THE PT RECOVERED FROM THE EVENT OF SYNOVITIS IN BOTH KNEES. ON (B)(6) 2005, THE PT UNDERWENT TOTAL KNEE REPLACEMENT (TKR). THE OUTCOME FOR THE EVENTS OF BILATERAL KNEE EFFUSION AND TKR WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENT OF SYNOVITIS AND BILATERAL KNEE EFFUSION WAS MILD AND WAS NOT PROVIDED FOR THE EVENT OF TKR. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS AS DEFINITELY RELATED; UNRELATED WITH TKR AND DID NOT PROVIDE THE RELATIONSHIP WITH THE EVENT FOR BILATERAL KNEE EFFUSION. FOLLOW-UP INFO WAS RECEIVED ON (B)(6) 2013 AND THE PT INITIALS WERE REPORTED AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178848 SYNVISC (HYLAND G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention