BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 6947193 · Received October 13, 2017

    Report

    Report Number
    2246315-2017-00158
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    January 1, 2016
    Report Date
    October 3, 2017
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS SOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 03-OCT-2017 FROM THE PATIENT VIA PATIENT SUPPORT PROGRAMME. PATIENT ID: (B)(6). STUDY ID: PATIENT SUPPORT PROGRAM INVOLVING SYNVISC ONE. THIS CASE CONCERNS A (B)(6) YEAR OLD FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCY THE PATIENT EXPERIENCED BONE ON BONE IN HER LEFT KNEE AND LEFT KNEE PAIN. NO RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED. PATIENT HAD BONE ON BONE IN HER LEFT KNEE AND LEFT KNEE PAIN AFTER SYNVISC ONE INJECTION ((B)(6) 2014). IT WAS REPORTED THAT THE PATIENT HAD THREE INJECTIONS OF SYNVISC ONE IN HER RIGHT KNEE WHICH WORKED WELL. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (DOSE, LOT NUMBER AND EXPIRATION DATE: NOT REPORTED) FOR ARTHRITIS. ON AN UNKNOWN DATE IN 2016 (EARLY 2016), UNKNOWN LATENCY OF RECEIVING THE INJECTION THE PATIENT EXPERIENCED BONE ON BONE IN HER LEFT KNEE AND LEFT KNEE PAIN. TREATMENT INCLUDED UNSPECIFIED SURGERY ON THE LEFT KNEE ON (B)(6) 2016. IT WAS REPORTED THAT KNEE PAIN WAS ONGOING BUT WAS NOT THAT BAD. PATIENT HAD LEFT KNEE SURGERY DUE TO BONE ON BONE. PATIENT MENTIONED THE REHABILITATION FOR THE LEFT KNEE HAD SOME ISSUES SO SHE STILL HAD SOME PAIN IN THE LEFT KNEE. CORRECTIVE TREATMENT: UNSPECIFIED SURGERY FOR BOTH. OUTCOME: UNKNOWN FOR BONE ON BONE IN HER LEFT KNEE; NOT RECOVERED FOR LEFT KNEE PAIN SERIOUSNESS CRITERION: HOSPITALIZATION AND REQUIRED INTERVENTION FOR BONE ON BONE IN HER LEFT KNEE. 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. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORS ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSES POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 09-OCT-2017. GLOBAL PTC NUMBER AND PTC RESULTS ADDED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 9-OCT-2017: THE FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE PREVIOUS CASE ASSESSMENT. THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND LATER EXPERIENCED LEFT KNEE PAIN DUE TO BONE AND BONE ON LEFT KNEE. A SIGNIFICANT TEMPORAL RELATIONSHIP CANNOT BE ESTABLISHED DUE TO LACK OF INFORMATION REGARDING THERAPY DATES AND HENCE CAUSAL ROLE OF SUSPECT CANNOT BE COMPLETELY DENIED IN OCCURRENCE OF THE EVENT ON THE BASIS OF SITE OF REACTION. HOWEVER, PATIENT'S UNDERLYING CONDITION OF ARTHRITIS IS A CONFOUNDER FOR THE CASE.

    Description of Event or Problem · 1

    THIS SOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2017 FROM THE PATIENT VIA PATIENT SUPPORT PROGRAM. (B)(6). STUDY ID: PATIENT SUPPORT PROGRAM INVOLVING SYNVISC ONE. THIS CASE CONCERNS A (B)(6) YEAR OLD FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND AFTER UNKNOWN LATENCY THE PATIENT EXPERIENCED BONE ON BONE IN HER LEFT KNEE AND LEFT KNEE PAIN. NO RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED. PATIENT HAD BONE ON BONE IN HER LEFT KNEE AND LEFT KNEE PAIN AFTER SYNVISC ONE INJECTION ((B)(6) 2014). IT WAS REPORTED THAT THE PATIENT HAD HAD THREE INJECTIONS OF SYNVISC ONE IN HER RIGHT KNEE WHICH WORKED WELL. ON AN UNKNOWN DATE, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (DOSE, LOT NUMBER AND EXPIRATION DATE: NOT REPORTED) FOR ARTHRITIS. ON AN UNKNOWN DATE IN 2016 (EARLY 2016), UNKNOWN LATENCY OF RECEIVING THE INJECTION THE PATIENT EXPERIENCED BONE ON BONE IN HER LEFT KNEE AND LEFT KNEE PAIN. TREATMENT INCLUDED UNSPECIFIED SURGERY ON THE LEFT KNEE ON (B)(6) 2016. IT WAS REPORTED THAT KNEE PAIN WAS ONGOING BUT WAS NOT THAT BAD. PATIENT HAD LEFT KNEE SURGERY DUE TO BONE ON BONE. PATIENT MENTIONED THE REHABILITATION FOR THE LEFT KNEE HAD SOME ISSUES SO SHE STILL HAD SOME PAIN IN THE LEFT KNEE. CORRECTIVE TREATMENT: UNSPECIFIED SURGERY FOR BOTH. OUTCOME: UNKNOWN FOR BONE ON BONE IN HER LEFT KNEE; NOT RECOVERED FOR LEFT KNEE PAIN. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: HOSPITALIZATION AND REQUIRED INTERVENTION FOR BONE ON BONE IN HER LEFT KNEE. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2017: THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND LATER EXPERIENCED LEFT KNEE PAIN DUE TO BONE AND BONE ON LEFT KNEE. A SIGNIFICANT TEMPORAL RELATIONSHIP CANNOT BE ESTABLISHED DUE TO LACK OF INFORMATION REGARDING THERAPY DATES AND HENCE CAUSAL ROLE OF SUSPECT CANNOT BE COMPLETELY DENIED IN OCCURRENCE OF THE EVENT ON THE BASIS OF SITE OF REACTION. HOWEVER, PATIENT'S UNDERLYING CONDITION OF ARTHRITIS IS A CONFOUNDER FOR THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728113 SYNVISC ONE INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R