BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 1469696 · Received September 10, 2009

    Report

    Report Number
    2246315-2009-00168
    Event Type
    Other
    Date Received
    September 10, 2009
    Date of Event
    September 2, 2009
    Report Date
    September 2, 2009
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #'S: Q0906, Q0910, Y0802. EVALUATION SUMMARY: THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER P0902, EXPIRY DATE 10/2011 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Y0802, EXPIRY DATE 11/2011 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Q0910, EXPIRY DATE 03/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Q0906, EXPIRY DATE 03/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    SEVERE EFFUSION [JOINT EFFUSION]. ACUTE JOINT SWELLING [JOINT SWELLING]. SEVERE PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2009 FROM A PHYSICIAN REGARDING A PT OF UNK GENDER AND INITIALS, WHO WAS BETWEEN 40 AND 60 YEARS OLD AND HAD A RELEVANT MEDICAL HISTORY OF MODERATE OA (OSTEOARTHRITIS) AND PREVIOUS SYNVISC INJECTIONS WITH NO PROBLEMS. THE PT RECEIVED THE FIRST INJECTION OF HIS OR HER MOST RECENT COURSE OF SYNVISC TREATMENT INTO AN UNK JOINT WITHIN THE PAST 10 DAYS. THE PHYSICIAN DID NOT KNOW WHICH LOT NUMBER OF SYNVISC WAS USED TO TREAT THE PT, BUT PROVIDED THE LOT NUMBERS WHICH WERE AVAILABLE IN THEIR OFFICE: P0902 (EXPIRATION DATE: OCT-2011), Q0906 (EXPIRATION DATE: MAR-2012), Q0910 (EXPIRATION DATE: MAR-2012), Y0802 (UNK EXPIRATION DATE). STARTING ON (B)(6) 2009, 1 TO 3 DAYS POST-INJECTION, THE PT EXPERIENCED SEVERE PAIN AND EFFUSION AND ACUTE SWELLING. THE EFFUSION WAS ASPIRATED AND SYNOVIAL FLUID WAS SENT TO THE LAB FOR ANALYSIS, THE RESULTS OF WHICH WERE STILL PENDING. THE PT WAS TREATED WITH EITHER IA (INTRA-ARTICULAR) OR ORAL STEROIDS. THE PHYSICIAN NOTED THAT THE PT WAS NOT "OBESE", WAS NOT AN ATHLETE (WITH POST-INJECTION EXERCISE), DID NOT COMPLAIN OF PAIN UPON INJECTION OF THE SYNVISC, AND HAD NOT EXPERIENCED THIS TYPE OF ADVERSE EVENT PREVIOUSLY. THE PT WAS NOT ON ANY CONCOMITANT MEDICATIONS AND HAD A DRY (NON-EFFUSED) KNEE PRIOR TO RECEIVING THE SYNVISC INJECTION. NO FURTHER INFO WAS PROVIDED. AS OF THE DATE OF RECEIPT OF THIS REPORT, THE PT OUTCOME WAS UNK. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2009. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER P0902, EXPIRY DATE 10/2011 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Y0802, EXPIRY DATE 11/2011 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Q0910, EXPIRY DATE 03/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER Q0906, EXPIRY DATE 03/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. (B)(4). MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY UNK P0902

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R