BEUDAMED
    FDA Adverse Event Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 2112496 · Received April 4, 2011

    Report

    Report Number
    2246315-2011-00061
    Date Received
    April 4, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    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 RESULTS WERE RECEIVED ON (B)(6) 2011. 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 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 THE REPORT.

    Description of Event or Problem · 1

    CRYSTALLINE ARTHRITIS [CRYSTAL ARTHROPATHY]. SWELLING [JOINT SWELLING]. KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2011 FROM AN ORTHOPEDIC SURGEON REGARDING A (B)(6) FEMALE PT, (B)(6), WITH A MEDICAL HISTORY OF GONARTHROSIS AND OSTEOPOROSIS. THE PT STARTED THE SYNVISC SERIES ON (B)(6) 2011 AND THE THIRD INJECTION WAS (B)(6) 2011. A FEW DAYS LATER, SWELLING DEVELOPED AT THE SITE OF GONARTHROSIS. A 20-30 CC OF JOINT FLUID WAS ASPIRATED BY PUNCTURE, THE FLUID WAS DENSE, OPACITY YELLOW. ON (B)(6) 2011, APPROXIMATELY ONE WEEK AFTER THE LAST INJECTION, THE SITE "CALMED DOWN" AND ALLEVIATED. THE REPORTING PHYSICIAN ASSESSED THE EVENT AS SERIOUS AND DEFINITELY RELATED TO SYNVISC. THE PHYSICIAN CONSIDERED THE EVENT WAS CRYSTALLINE ARTHRITIS. CONCOMITANT MEDICATIONS INCLUDED ALFACALCIDOL, START DATE (B)(6) 2008, 1.0 UG QD, SODIUM RISEDRONATE HYDRATE START DATE (B)(6) 2008, 17.5 MG, QW; KETOPROFEN, AND DICLOFENAC SODIUM, START DATE (B)(6) 2008, 50 MG. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2011 FROM THE REPORTING PHYSICIAN. THE PT'S INITIALS WERE UNK. THE EVENT OF ARTHRITIS WAS REPORTED AS SERIOUS. THE OUTCOME WAS UNK. NO FURTHER INFO WAS PROVIDED.

    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 71 YR Other ALFACALCIDOL (ALFACALCIDOL) UNK| RISEDRONATE SODIUM (RISEDRONATE SODIUM) UNK| KETOPROFEN (KETOPROFEN) UNK| DICLOFENAC SODIUM (DICLOFENAC SODIUM) UNK