BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNVISC (HYLAN G-F 20) INJECTION

    MDR report key: 3057407 · Received April 10, 2013

    Report

    Report Number
    2246315-2013-00072
    Event Type
    Other
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 29, 2013
    Manufacturer
    GENZYME CORPORATION
    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

    ADD'L INFO WAS RECEIVED ON (B)(4) 2013 IN THE FORM OF QA (QUALITY ASSURANCE) INVESTIGATION RESULTS. 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 RESULTS 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

    SWELLING OF KNEE [JOINT SWELLING]. JOINT EFFUSION. PAIN. DIFFICULTY IN WALKING [GAIT DISTURBANCE]. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, (B)(6), WITH GONARTHROSIS (WITH KNEE PAIN). THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR PREVIOUS USE OF SYNVISC (HYLAN G-F 20) TWICE (FIRST COURSE FROM (B)(6) 2012 AND SECOND COURSE FROM (B)(6) 2012). ON (B)(6) 2013, THE PATIENT INITIATED TREATMENT WITH SYNVISC INJECTION AT A DOSE OF 2ML, 1/1 DAY, ROUTE AND FREQUENCY NOT PROVIDED. THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2013, THE PATIENT EXPERIENCED PAIN. ON (B)(6) 2013, THE PATIENT VISITED THE REPORTING HOSPITAL FOR HAVING DIFFICULTY IN WALKING AND SWELLING OF KNEE WAS OBSERVED FOR WHICH JOINT FLUID OF 75 ML WAS ASPIRATED BY ARTHROCENTESIS. THE SAME DAY, THE PATIENT HAD JOINT LAVAGE WITH SALINE AND XYLOCAINE (LIDOCAINE) WAS ADMINISTERED. AFTER THAT, THE PATIENT WENT HOME WITH USE OF CRUTCHES. ON (B)(6) 2013, PAIN WAS SLIGHTLY ALLEVIATED. ON UNSPECIFIED DATES, BLOOD CULTURE AND SYNOVIAL FLUID CULTURE FOR CRYSTAL OF PYROPHOSPHATE WERE FOUND TO BE NEGATIVE. ON (B)(6) 2013, THE PATIENT RECEIVED TREATMENT WITH ARTZ (HYALURONATE SODIUM) AND XYLOCAINE. AFTER THAT, THE PAIN IMPROVED TO THE USUAL LEVEL. ON (B)(6) 2013, THE EVENT OF SWELLING OF KNEE WAS RESOLVED. THE EVENT OF SWELLING OF KNEE WAS CONSIDERED SERIOUS DUE TO PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY. THE ACTION TAKEN WITH SYNVISC TREATMENT WAS NOT PROVIDED. THE OUTCOME FOR THE EVENTS OF DIFFICULTY IN WALKING AND JOINT EFFUSION WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS INCLUDED LOXONIN (LOXOPROFEN) AND CELCOX (CELECOXIB). THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SWELLING OF KNEE AS DEFINITE AND DID NOT PROVIDE RELATIONSHIP BETWEEN SYNVISC AND THE EVENT OF SWELLING OF KNEE AS DEFINITE AND DID NOT PROVIDE RELATIONSHIP BETWEEN SYNVISC AND THE EVENTS OF PAIN, DIFFICULTY IN WALKING, JOINT EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149950 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention| S