BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC (SYNVISC)

    MDR report key: 3402950 · Received October 7, 2013

    Report

    Report Number
    2246315-2013-00448
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    July 29, 2013
    Report Date
    August 29, 2013
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    PMA P940015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H3 EVAL SUMMARY: THE QA (QUALITY ASSURANCE) INVESTIGATION SUMMARY WAS RECEIVED ON (B)(4) 2013. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER N12015, WITH EXPIRATION DATE 2014-11 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 N12015, NO CAPA IS REQUIRED. PHARMACOVIGILANCE COMMENT: MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF SYNVISC IS NOT AFFECTED BY THIS REPORT. FOLLOW UP COMMENT: SANOFI COMPANY FOLLOW UP COMMENT DATED (B)(4) 2013; THIS FOLLOW-UP PROVIDES SPRAIN AS AN ALTERNATE CAUSE OF PATIENT'S MEDIAL MENISCUS INJURY OF LEFT KNEE AFTER RECEIVING TREATMENT WITH SYNVISC FOR OSTEOARTHRITIS.

    Description of Event or Problem · 1

    UPON RECEIPT OF FOLLOW UP INFORMATION ON (B)(6) 2013, THE CASE TYPE WAS CHANGED FROM UNSOLICITED TO SOLICITED. THIS SERIOUS SOLICITED DEVICE CASE FROM THE STUDY (B)(6) WAS RECEIVED ON (B)(6) 2013 FROM AN ORTHOPEDIST. PATIENT ID: (B)(6); COUNTRY: (B)(6). STUDY TITLE: (B)(6). THIS CASE CONCERNS A (B)(6) FEMALE PATIENT WHO HAD MEDIAL MENISCUS INJURY OF LEFT KNEE/ SPRAIN AFTER RECEIVING HYLAN G-F 20 (SYNVISC). THE PATIENT HAD A MEDICAL HISTORY OF MILD LEFT KNEE OSTEOARTHRITIS WITHOUT PRIOR EFFUSION, JOINT NARROWING AND OSTEOPHYTES. PAST DRUGS INCLUDED GLUCOSAMINE HYDROCHLORIDE CAPSULES. ON (B)(6) 2013, THE PATIENT COMMENCED TREATMENT WITH HYLAN GF-20 INJECTION AT A DOSE OF 02 ML ONCE A WEEK IN THE LEFT KNEE (ROUTE OF ADMINISTRATION, BATCH NUMBER N12015, EXPIRATION: 2014/11) FOR OSTEOARTHRITIS OF LEFT KNEE. ON (B)(6) 2013, THE PATIENT RECEIVED THE SECOND HYLAN G-F 20 INJECTION. ON 1(B)(6) 2013, THE PATIENT RECEIVED THE THIRD INJECTION OF HYLAN G-F 20 IN LEFT KNEE. ON UNSPECIFIED DATE, PATIENT DEVELOPED A SPRAIN. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH LEFT KNEE PAIN CAUSED BY SPRAIN (FOUR MONTHS AGO) AND WAS DIAGNOSED WITH SEVERE MEDIAL MENISCUS INJURY OF THE LEFT KNEE (CONFIRMED BY MAGNETIC RESONANCE IMAGING). SPRAIN WAS THE POSSIBLE PRECIPITATING FACTOR FOR DEVELOPMENT OF MEDIAL MENISCUS INJURY OF THE LEFT KNEE. ON (B)(6) 2013, THE PATIENT UNDERWENT KNEE ARTHROSCOPY SURGERY AND THE LEFT KNEE WAS DEBRIDED. IT WAS REPORTED THAT POST-OPERATIVE RECOVERY WAS GOOD. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON DISCHARGE, THE PATIENT'S GENERAL CONDITION WAS GOOD, WITH SOME MILD LEFT KNEE SWELLING STILL PERSISTING. ON (B)(6) 2013, THE PATIENT RECOVERED FROM THE EVENT OF MEDIAL MENISCUS INJURY OF THE LEFT KNEE / SPRAIN. CAUSALITY: NOT RELATED. (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 REGARDING THE UPDATE IN CASE TYPE, PATIENT'S MEDICAL HISTORY AND CLINICAL COURSE. BOTH OF THIS INFORMATION WAS PROCESSED TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506916 SYNVISC (SYNVISC) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) N12015

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R CON MEDS: UNK| GLUCOSAMINE HYDROCHLORIDE (PREV.)