BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 4152412 · Received August 4, 2014

    Report

    Report Number
    2246315-2014-01778
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 28, 2014
    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

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014. THE PTC INVESTIGATION RESULTS WERE ADDED.

    Description of Event or Problem · 1

    THIS UNSOLICITED DEVICE CASE RECEIVED FROM (B)(6) ON (B)(6) 2014 FROM AN ORTHOPEDIST VIA A MARKETING PARTNER (B)(4). THE CASE INVOLVES A (B)(6) YEAR OLD FEMALE PATIENT WHO EXPERIENCED PAIN IN AND SWELLING OF THE RIGHT KNEE AFTER RECEIVING TREATMENT WITH SYNVISC INJECTION. IT WAS REPORTED THAT PATIENT'S JOINT FLUID WAS ASPIRATED (EFFUSION OF RIGHT KNEE). RELEVANT MEDICAL HISTORY INCLUDED GONARTHROSIS RIGHT. CONCOMITANT MEDICATIONS REPORTED INCLUDE LOXOPROFEN SODIUM (LOXININ), REBAMIPIDE (MUCOSTA) AND FLURBIPROFEN (ADOFEED). NO PAST DRUGS AND CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2014, THE PATIENT RECEIVED FIRST INTRA-ARTICULAR SYNVISC INJECTION, AT A DOSE OF 02 ML, WEEKLY, (BATCH/LOT NUMBER AND EXPIRATION DATE: UNK) INTO THE RIGHT KNEE FOR GONARTHROSIS. ON (B)(6) 2014, SHE RECEIVED THE SECOND SYNVISC INJECTION. ON (B)(6) 2014, SHE RECEIVED THE THIRD SYNVISC INJECTION INTO THE RIGHT KNEE. ON (B)(6) 2014, SHE EXPERIENCED PAIN IN AND SWELLING OF THE RIGHT KNEE. ON (B)(6) 2014, 20 ML OF JOINT FLUID WAS ASPIRATED BY PARACENTESIS AND CORTICOSTEROID NOS (STEROID) WAS INFUSED. THE SYNOVIAL FLUID ANALYSIS SHOWED NEUTROPHIL, 3+; LYMPHOCYTE, 2+; CELL COUNT, 4750 AND PYROPHOSPHATE WAS NEGATIVE. IT WAS REPORTED THAT SHE DID NOT VISIT THE HOSPITAL AFTERWARDS. OUTCOME: UNK FOR ALL EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA WAS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT SAFETY. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. PAIN IN THE RIGHT KNEE (ACHING [R] KNEE): REPORTING ORTHOPEDIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE. SWELLING OF THE RIGHT KNEE (SWELLING OF R KNEE): REPORTING ORTHOPEDIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE. SERIOUSNESS CRITERION: REQUIRED INTERVENTION FOR ALL THE EVENTS. NO FURTHER INFORMATION WAS EXPECTED BECAUSE THE REPORTER WAS BUSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453752 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ADOFEED (CON.) - UNK - ONGOING| LOXONIN (CON.) - UNK - ONGOING| MUCOSTA (CON.) - UNK - ONGOING