BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC ONE (HYLAN G-F 20) INJECTION

    MDR report key: 1912800 · Received November 3, 2010

    Report

    Report Number
    2246315-2010-00227
    Event Type
    Other
    Date Received
    November 3, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    RIGHT KNEE BECAME SWOLLEN [JOINT SWELLING], FLUID WAS REMOVED FROM RIGHT KNEE [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN VIA A COMPANY REPRESENTATIVE REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF OSTEOARTHRITIS OF THE KNEE AND PREVIOUS SYNVISC-ONE ADMINISTRATION ON (B)(6) 2010 IN THE RIGHT KNEE. THE PT WAS ADMINISTERED SYNVISC-ONE ON (B)(6) 2010. THE PHYSICIAN STATED THAT ON (B)(6) 2010, THE PT'S RIGHT KNEE BECAME SWOLLEN AND 36 CC (CUBIC CENTIMETERS) OF SYNOVIAL FLUID WAS REMOVED FROM THE PT'S RIGHT KNEE. A SYNOVIAL FLUID CULTURE WAS NEGATIVE. ANOTHER 10 CC OF FLUID WAS ASPIRATED ON (B)(6) 2010. AT THE TIME OF THIS REPORT, THE OUTCOMES OF THE EVENTS WERE UNK. THE SYNVISC-ONE LOT NUMBER WAS UNK. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010 FROM THE PHYSICIAN REGARDING THE PT. HE REPORTED THAT THE PT HAD A MEDICAL HISTORY OF OSTEOARTHRITIS WHICH STARTED ON AN UNK DATE IN 2006 WITH A MODERATE GRADE, PREVIOUS TREATMENT WITH NSAIDS (NON-STEROIDAL ANTIINFLAMMATORIES), STEROIDS, AND HYALGAN, JOINT NARROWING, AND OSTEOPHYTES. THE PT DID NOT HAVE A HISTORY OF PRIOR EFFUSION. CONCOMITANT MEDICATION DURING SYNVISC-ONE ADMINISTRATION WAS KENALOG (TRIAMCINOLONE ACETONIDE). THE PHYSICIAN STATED THAT SYNVISC-ONE WAS INJECTED ON (B)(6) 2010 AND NO EFFUSION WAS COLLECTED PRIOR TO THE FIRST INJECTION. THE RIGHT KNEE BECAME SWOLLEN ON (B)(6) 2010. THE RELATION TO SYNVISC-ONE WAS DEFINITE AND THE INTENSITY OF THE SYMPTOM WAS SEVERE. TREATMENT INCLUDED ASPIRATION OF 36 ML OF THE KNEE ON (B)(6) 2010. A C+S (CULTURE AND SENSITIVITY) ANALYSIS WAS PERFORMED. THE GRAM STAIN REPORT STATED THAT NO ORGANISMS WERE SEEN, THERE WERE FEW POLYMORPHONUCLEAR LEUKOCYTES, AND THERE WAS NO GROWTH AFTER 48 HOURS. THE PHYSICIAN REPORTED THAT AT F/U ONE WEEK LATER, THE PT WAS INJECTED WITH KENALOG "WITH IMPROVEMENT." THE EVENT OF RIGHT KNEE SWOLLEN WAS RECOVERED WITH SEQUELAE ON (B)(6) 2010. NO FURTHER INFO WAS PROVIDED. MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT.

    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 BIOSURGERY (RIDGEFIELD) UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention