BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2223830 · Received August 18, 2011

    Report

    Report Number
    2246315-2011-00201
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. EVAL 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 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.

    Description of Event or Problem · 1

    SEPTIC REACTION [ARTHRITIS BACTERIAL]. JOINT INSTABILITY [JOINT INSTABILITY]. JOINT STIFFNESS [JOINT STIFFNESS]. JOINT PAIN [ARTHRALGIA]. PAIN WITH FIRST AND SECOND SYNVISC INJECTIONS [INFECTION SITE PAIN]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011 FROM A PHYSICIAN, REGARDING A FEMALE PT (INITIALS AND DATE OF BIRTH UNK). THE PT'S MEDICAL HISTORY IS SIGNIFICANT FOR MULTIPLE SCLEROSIS AND PREVIOUS TREATMENT WITH SYNVISC IN 2009. ON AN UNSPECIFIED DATE IN 2011, THE PT INITIATED THE FIRST SYNVISC INJECTION OF 2 ML INTO BOTH KNEES. THE SYNVISC LOT NUMBER WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN 2011, THE PT INITIATED THE SECOND SYNVISC INJECTION OF 2 ML INTO BOTH KNEES. THE PHYSICIAN REPORTED THAT THE PT EXPERIENCED PAIN DURING THE FIRST AD SECOND SYNVISC INJECTIONS. THE PHYSICIAN ALSO BELIEVES THAT THE PT HAS HAD A SEPTIC REACTIONS, AFTER RECEIVING THE SECOND SYNVISC INJECTION. THE PHYSICIAN REPORTED THAT THE PT DOES NOT HAVE SWELLING, BUT IS CURRENTLY EXPERIENCING JOINT PAIN THAT CONTINUES TO WORSEN, SOME JOINT STIFFNESS AND INSTABILITY IN THE JOINT. ON AN UNSPECIFIED DATE IN 2011, THE PT WAS TREATED WITH ORAL STEROIDS. THE PT'S OUTCOME FOR THE EVENTS OF "JOINT PAIN, JOINT STIFFNESS AND INSTABILITY IN THE JOINT" WAS REPORTED AS NOT YET RECOVERED. THE PT'S OUTCOME FOR THE EVENTS OF "PAIN WITH FIRST AND SECOND SYNVISC INJECTIONS AND SEPTIC REACTION" WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF 'SEPTIC REACTION, JOINT PAIN, JOINT STIFFNESS, INSTABILITY IN THE JOINT AND PAIN WITH FIRST AND SECOND SYNVISC INJECTION" WAS NOT PROVIDED BY THE REPORTING PHYSICIAN. ADD'L INFO WAS RECEIVED ON (B)(6) 2011 IN THE FORM OF A QA INVESTIGATION 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 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.

    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 (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention