BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3085105 · Received April 25, 2013

    Report

    Report Number
    2246315-2013-00290
    Event Type
    Other
    Date Received
    April 25, 2013
    Date of Event
    March 1, 2013
    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 APRIL 12, 2013. 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 SPEC CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPEC 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. MFR'S COMMENT: THIS CASE REPORT BELONGS TO A BATCH OF ICSRS FROM A DATABASE EXTRACTION CONTAINING A COLLECTION OF DATA FROM OCTOBER 1997 TO JULY 2010. THE BENEFIT RISK PROFILE OF THE PRODUCT IS NOT ALTERED BY THIS REPORT.

    Description of Event or Problem · 1

    SYNOVITIS [SYNOVITIS]. KNEE EFFUSION (BOTH KNEES) [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2013 FROM A PHYSICIAN DATABASE EXTRACTION REGARDING A MALE PT (AGE NOT PROVIDED), INITIALS UNK WITH OSTEOARTHRITIS (KELLGREN & LAWRENCE GRADE 4 WITH NO PRIOR EFFUSION). THIS CASE BELONGS TO A BATCH OF ICSRS FROM A COMPANY PURCHASED DATABASE CONTAINING A COLLECTION OF DATA FROM OCTOBER 1997 TO JULY 2010. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS MEDICAL DEVICE IMPLANTATION WITH SYNVISC (HYLAN G-F 20); (FIRST COURSE IN RIGHT KNEE AND THREE COURSES IN LEFT KNEE). ON (B)(6) 2003, THE PT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION OF SECOND COURSE IN RIGHT KNEE AND FOURTH COURSE IN LEFT KNEE, DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON (B)(6) 2003, THE PT EXPERIENCED SYNOVITIS OF BOTH KNEES. ON UNSPECIFIED DATES IN (B)(6) 2003, 35 CC FLUID WAS ASPIRATED FROM RIGHT KNEE AND 40 CC FLUID ASPIRATED FROM LEFT KNEE WHICH ARE TURBID YELLOW (MODERATE KNEE EFFUSION; BOTH KNEES). ON (B)(6) 2003, THE PT AGAIN EXPERIENCED SYNOVITIS OF BOTH KNEES. ON UNSPECIFIED DATES IN (B)(6) 2003, 26 CC FLUID WAS ASPIRATED FROM RIGHT KNEE AND 18 CC FLUID ASPIRATED FROM LEFT KNEE WHICH WAS CLEAR YELLOW (MID KNEE EFFUSION; BOTH KNEES). IT WAS REPORTED THAT THE PT RECEIVED TREATMENT WITH INTRA MUSCULAR BETAMETHASONE, AT A DOSE OF 1.3 CC FOR THE EVENTS OF SYNOVITIS OF BOTH KNEES AND KNEE EFFUSION IN BOTH KNEES. ON (B)(6) 2003 (AFTER EIGHT DAYS), THE PT RECOVERED FROM THE EVENT OF SYNOVITIS OF BOTH KNEES. ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENT OF KNEE EFFUSION IN BOTH KNEES WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDE. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SYNOVITIS OF BOTH KNEES AS DEFINITE AND DID NOT PROVIDE THE RELATIONSHIP WITH KNEE EFFUSION IN BOTH KNEES. F/U 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
    179623 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention