BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 2249648 · Received August 26, 2011

    Report

    Report Number
    2246315-2011-00207
    Event Type
    Other
    Date Received
    August 26, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 14, 2011
    Manufacturer
    GENZYME CORPORATION
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER (B)(4), EXPIRATION DATE 03/2014, WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    LACK OF RANGE OF MOTION KNEES [JOINT RANGE OF MOTION DECREASED]. EXTREME SWELLING IN BOTH KNEES [JOINT SWELLING]. EXTREME PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2011, FROM A PHYSICIAN ASSISTANT VIA A COMPANY REP REGARDING A FEMALE PT OF UNK AGE, UNK INITIALS ON (B)(6) 2011, THE PT INITIATED 6 ML SYNVISC-ONE INJECTION INTO BOTH KNEES FOR OSTEOARTHRITIS. A VALID LOT NUMBER WAS NOT PROVIDED. ON (B)(6) 2011, THE PT EXPERIENCED EXTREME SWELLING IN BOTH KNEES, WITH EXTREME PAIN AND LACK OF RANGE OF MOTION. THE PT REQUIRED CRUTCHES AS A RESULT OF THESE NON-SERIOUS EVENTS. THE ACTION TAKEN WITH SYNVISC-ONE TREATMENT WAS NOT PROVIDED. THE PT'S OUTCOME WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ADD'L INFO WAS RECEIVED ON (B)(4) 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 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. ADD'L INFO WAS RECEIVED ON (B)(4) 2011, FROM THE PHYSICIAN ASSISTANT. THE PT'S MEDICAL HISTORY WAS SIGNIFICANT FOR MODERATE OSTEOARTHRITIS INCLUDING JOINT NARROWING AND OSTEOPHYTES. THE PT HAD NO HISTORY OF PRIOR KNEE EFFUSION. PREVIOUS TREATMENT WAS REPORTED AS NSAIDS, STEROIDS AND SYNVISC. THE PHYSICIAN CONFIRMED THAT ON (B)(4) 2011, THE PT INITIATED SYNVISC-ONE INJECTION, 6 ML, INTO BOTH KNEES, LOT # Q11041. ON (B)(6) 2011, THE PT EXPERIENCED EXTREME SWELLING AND PAIN OF BOTH KNEES AND LACK OF RANGE OF MOTION OF BOTH KNEES. TREATMENT FOR THESE VENTS INCLUDED ICE, PREDNISONE, NSAIDS, AND TRAMADOL. THE USE OF STEROIDS IS CONSIDERED SERIOUS. THE ACTION TAKEN WITH SYNVISC-ONE WAS NOT REPORTED. ON (B)(6) 2011, THE PT RECOVERED FROM THE EXTREME SWELLING IN BOTH KNEES AND RECOVERED WITH SEQUELAE FROM THE EXTREME PAIN IN BOTH KNEES AND LACK OF RANGE OF MOTION. THE INTENSITY FOR THE EVENTS OF EXTREME SWELLING AND KNEE PAIN WAS ASSESSED AS MODERATE AND LACK OF RANGE OF MOTION WAS ASSESSED AS SEVERE. THE REPORTING PHYSICIAN ASSISTANT ASSESSED THE RELATIONSHIP BETWEEN SYNVISC-ONE AND THE EVENTS OF EXTREME SWELLING, PAIN, AND LACK OF RANGE OF MOTION IN BOTH KNEES AS RELATED. ADD'L INFO WAS RECEIVED ON (B)(4) 2011, IN THE FORM OF A QA INVESTIGATION SUMMARY. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER (B)(4) EXPIRATION DATE 03/2014 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNVISC ONE (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK Q11041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention