BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 3890788 · Received June 4, 2014

    Report

    Report Number
    2246315-2014-48472
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 2014
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC} WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER 81303, WITH EXPIRATION DATE (05/2016} WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT NUMBER BATCH RECORD REVIEW AND LOT NUMBER FREQUENCY ANALYSIS FOR LOT NUMBER S1303, NO CAPA WAS REQUIRED. REPORTER'S CAUSALITY ASSESSMENT: RELATED. SERIOUSNESS CRITERIA: INTERVENTION REQUIRED ((PATIENT RECEIVED TREATMENT WITH METHYLPREDNISOLONE ACETATE (DEPO­ MEDROL)). FOLLOW UP INFORMATION WAS RECEIVED ON (B)(4) 2014. AS THE PTC INVESTIGATION REPORT WAS RECEIVED WITHOUT BATCH/LOT NUMBER; THUS THE FOLLOW UP WAS PROCESSED AS NO NEW SAFETY INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014. THE PTC RESULTS WERE ADDED AND THE TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014 FROM THE MEDICAL ASSISTANT. THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS: THE PATIENT RECEIVED TREATMENT WITH STEROID (REQUIRED INTERVENTION} FOR THE EVENT. THE PATIENT'S AGE AND DATE OF BIRTH WERE ADDED. RELEVANT MEDICAL HISTORY, CONCURRENT CONDITIONS, CONCOMITANT MEDICATION AND DATE OF PREVIOUS USE OF SYNVISC ONE WAS ADDED. LABORATORY RESULTS WERE UPDATED. THE EVENT OF PSEUDOSEPTIC REACTION WAS ADDED AND PREVIOUSLY REPORTED EVENTS OF SWELLING IN RIGHT KNEE, PAINFUL RIGHT KNEE AND KNEE DRAINED WERE CONSIDERED AS ITS SYMPTOMS. TREATMENT MEDICATIONS WERE ADDED. OUTCOME WAS UPDATED FROM UNKNOWN TO RECOVERED. ADDITIONAL REPORTER WAS ADDED. THE REPORTER'S CAUSALITY ASSESSMENT FOR SYNVISC ONE WITH THE EVENT WAS REPORTED AS RELATED. CLINICAL COURSE UPDATED. TEXT AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014, THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE PATIENT RECEIVED TREATMENT WITH STEROID (REQUIRED INTERVENTION) FOR THE EVENT OF PSEUDOSEPTIC REACTION. THIS UNSOLICITED DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(4) 2014 FROM A PHYSICIAN. BASED ON ADDITIONAL INFORMATION RECEIVED ON(B)(4) 2014, THE EVENT OF PSEUDOSEPTIC REACTION WAS ADDED AND REPORTED EVENTS OF SWELLING IN RIGHT KNEE, PAINFUL RIGHT KNEE AND KNEE DRAINED WERE CONSIDERED AS ITS SYMPTOMS. THIS CASE CONCERNS (B)(6) YEAR OLD FEMALE PATIENT OF WHO DEVELOPED PSEUDOSEPTIC REACTION AFTER RECEIVING TREATMENT WITH SYNVISC ONE. THE PATIENT'S PAST DRUG INCLUDED SYNVISC ONE (ON (B)(6) 2013 WITH NO PROBLEMS), MEDICAL HISTORY INCLUDED ANTERIOR CRUCIATE LIGAMENT TEAR AND EPILEPSY. CONCOMITANT MEDICATIONS INCLUDED FOLIC ACID, LAMOTRIGINE (LAMICTAL), CHOLECALCIFEROL (VITAMIN D3) AND FISH OIL (OMEGA 3). IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH GRADE 2 OSTEOARTHRITIS FROM RIGHT KNEE XRAY DONE ON (B)(6) 2012. ON (B)(6) 2014, THE PATIENT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION, AT THE DOSE OF 6 ML, ONCE (ROUTE OF ADMINISTRATION, LOT/BATCH NUMBER: S1303 AND EXPIRATION DATE 31-MAY-2016) INTO RIGHT KNEE FOR OSTEOARTHRITIS. ON (B)(6) 2014, THE PATIENT DEVELOPED MARKED SWELLING OF RIGHT KNEE WHICH WAS SUGGESTIVE OF PSEUDOSEPTIC REACTION. THE PATIENT WAS ADMINISTERED TREATMENT WITH DICLOFENAC POTASSIUM (VOLTAREN) GEL AND ICE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PAINFUL RIGHT KNEE. ON (B)(6) 2014, 50 CC OF SYNOVIAL FLUID WAS ASPIRATED FROM RIGHT KNEE. THE PATIENT RECEIVED TREATMENT WITH METHYLPREDNISOLONE ACETATE (DEPO-MEDROL} FOR SYMPTOMATIC RELIEF. OUTCOME: RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327491 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) S1303

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention VITAMIN D3 (CON.)| OMEGA 3 (CON.)| SYNVISC ONE (PREV.)| FOLIC ACID (CON.)| LAMICTAL (CON.)