BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2671094 · Received July 19, 2012

    Report

    Report Number
    2246315-2012-00204
    Event Type
    Other
    Date Received
    July 19, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 11, 2012
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2012. 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. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    FLUID RETENTION [FLUID RETENTION]. PAIN [PAIN]. SWELLING [SWELLING]. JOINT EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012 FROM A PHYSICIAN REGARDING A (B)(6) MALE PATIENT, INITIALS UNKNOWN, WITH GONARTHROSIS. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PRIOR USE OF SYNVISC: FIRST COURSE FROM (B)(6)2011 AND SECOND COURSE FROM (B)(6) 2012. THERE WAS NO PROBLEM WITH PREVIOUS TWO SYNVISC COURSES. ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH FIRST INJECTION OF THIRD COURSE OF SYNVISC (HYLAN G-F 20) INTO LEFT KNEE, DOSAGE REGIMEN NOT PROVIDED. THE LOT NUMBER OF SYNVISC WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT DEVELOPED PAIN AFTER 4 HOURS OF FIRST INJECTION AND HAD FLUID RETENTION. ON AN UNSPECIFIED DATE, IN (B)(6) 2012, HE DEVELOPED SWELLING AND HAD JOINT EFFUSION. ON (B)(6) 2012, THE PATIENT HAD ARTHROCENTESIS WITH AMOUNT OF FLUID ASPIRATED 40 CC. HE TOOK UNSPECIFIED ANTIBIOTIC AND NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID), ORALLY. ON (B)(6) 2012, THE PATIENT AGAIN HAD ARTHROCENTESIS AND THE AMOUNT OF FLUID ASPIRATED WAS 50 CC. CULTURE TEST WAS NEGATIVE. ON (B)(6) 2012, THE PATIENT HAD ARTHROCENTESIS THIRD TIME WITH AMOUNT OF FLUID ASPIRATED 40 CC. THE SAME DAY, HE HAD AN INTRA-ARTICULAR INJECTION OF TRIAMCINOLONE ACETONIDE AT A DOSE OF 20 MG AND SWELLING AND FLUID RETENTION ALLEVIATED. THE EVENT OF FLUID RETENTION WAS ASSESSED AS MEDICALLY SIGNIFICANT. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF PAIN AND JOINT EFFUSION WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF FLUID RETENTION AND SWELLING WAS NOT YET RECOVERED. RELEVANT CONCOMITANT MEDICATIONS REPORTED INCLUDE LOXOPROFEN SODIUM HYDRATE. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF FLUID RETENTION AS DEFINITE. THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF PAIN, SWELLING AND JOINT EFFUSION WERE NOT PROVIDED BY THE REPORTER. THE PHYSICIAN REPORTED THAT HE WAS INSTRUCTED TO HAVE REST AFTER THE INJECTION, THEREFORE IT WAS HARDLY CONSIDERED THAT ACUTE BURDEN CAUSED THE EVENT DUE TO MOBILITY IMPROVEMENT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R