BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE

    MDR report key: 6785094 · Received August 10, 2017

    Report

    Report Number
    2246315-2017-00126
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    February 27, 2019
    Manufacturer
    GENZYME CORPORATION(RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY FOLLOWING OFF LABEL USE OF SYNVISC ONE [INFLAMMATORY POLYARTHRITIS] ([JOINT PAIN], [JOINT SWELLING], [OFF LABEL USE]). CASE NARRATIVE: THIS UNSOLICITED LITERATURE CASE FROM UNITED STATES WAS RECEIVED ON 28-JUL-2017 FROM A CONFERENCE ABSTRACT: KOCAK D, ANNASWAMY T, CHONG S, ARORA R. DEVELOPMENT OF SYSTEMIC INFLAMMATORY POLYARTHRITIS AFTER ZYGAPOPHYSEAL JOINT INJECTION WITH HYLAN G-F 20 (SYNVISC-ONE). AM J PHYS MED REHABIL. 2018:97(2):147-9. DOI: 10.1097/PHM.0000000000000797. ACCESSED ON: 2018 FEB 01. THIS CASE CONCERNS A 72 YEAR OLD MALE PATIENT WHO WAS INJECTED WITH SYNVISC ONE IN LUMBAR ZYGAPOPHYSEAL JOINT (OFF LABEL USE) AND LATER AFTER 2 DAYS EXPERIENCED SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. NO MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS REPORTED. ON AN UNKNOWN DATE, PATIENT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION, AT A DOSE OF 6 ML, ONCE (ROUTE, INDICATION, LOT NUMBER AND EXPIRY DATE: NOT PROVIDED) IN LUMBAR ZYGAPOPHYSEAL JOINT (OFF LABEL USE). ON AN UNKNOWN DATE, 2 DAYS AFTER THE INJECTION, PATIENT HAD BILATERAL, DIFFUSE, JOINT PAIN AND SWELLING WITH ELEVATED INFLAMMATORY MARKERS SUGGESTIVE OF A SYSTEMIC INFLAMMATORY POLYARTHROPATHY THAT DEVELOPED ACUTELY 2 DAYS AFTER LUMBAR ZYGAPOPHYSEAL JOINT INJECTION WITH SYNVISC ONE. SERIOUSNESS CRITERIA: HOSPITALIZATION AND MEDICALLY SIGNIFICANT. ACTION TAKEN: NOT APPLICABLE. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. 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 HAS NOT INDICATED ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER'S CAUSALITY DESCRIPTION: ADVERSE EFFECTS; THE MOST COMMON BEING LOCAL PAIN OR SWELLING. ADDITIONAL INFORMATION WAS RECEIVED ON 07-AUG-2017. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 17-FEB-2019 VIA LITERATURE ABSTRACT: LITERATURE REFERENCE WAS UPDATED. DEVICE CODES WERE ADDED. EVENT OF SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY FOLLOWING OFF LABEL USE OF SYNVISC ONE WAS UPDATED FROM SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY AND EVENT OF OFF LABEL USE WAS UPDATED AS A SYMPTOM FOR SAME. SERIOUSNESS CRITERIA OF MEDICALLY SIGNIFICANT WAS ADDED. LAB TEST OF ELEVATED INFLAMMATORY MARKERS ELEVATED WAS ADDED. NARRATIVE WAS UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    THIS UNSOLICITED LITERATURE CASE FROM UNITED STATES WAS RECEIVED ON 28-JUL-2017 FROM A CONFERENCE ABSTRACT: KOCAK D, ANNASWAMY T, CHONG S, ARORA R. DEVELOPMENT OF SYSTEMIC INFLAMMATORY POLYARTHRITIS AFTER ZYGAPOPHYSEAL JOINT INJECTION WITH HYLAN G-F 20 (SYNVISC-ONE). AM J PHYS MED REHABIL. 2017 JUL 13. DOI: 10.1097/ PHM.0000000000000797. THIS CASE CONCERNS A( B)(6) YEAR OLD MALE PATIENT WHO WAS INJECTED WITH SYNVISC ONE IN LUMBAR ZYGAPOPHYSEAL JOINT (OFF LABEL USE) AND LATER AFTER 2 DAYS EXPERIENCED SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. NO MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS REPORTED. ON AN UNKNOWN DATE, PATIENT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION, AT A DOSE OF 6 ML, ONCE (ROUTE, INDICATION, LOT NUMBER AND EXPIRY DATE: NOT PROVIDED) IN LUMBAR ZYGAPOPHYSEAL JOINT (OFF LABEL USE). ON AN UNKNOWN DATE, 2 DAYS AFTER THE INJECTION, PATIENT HAD BILATERAL, DIFFUSE, JOINT PAIN AND SWELLING WITH ELEVATED INFLAMMATORY MARKERS SUGGESTIVE OF A SYSTEMIC INFLAMMATORY POLYARTHROPATHY THAT DEVELOPED ACUTELY 2 DAYS AFTER LUMBAR ZYGAPOPHYSEAL JOINT INJECTION WITH SYNVISC ONE. CORRECTIVE TREATMENT: NOT REPORTED FOR SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY, POLYARTHROPATHY. OUTCOME: UNKNOWN FOR SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. 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 HAS NOT INDICATED ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER'S CAUSALITY: ADVERSE EFFECTS; THE MOST COMMON BEING LOCAL PAIN OR SWELLING SERIOUSNESS CRITERIA: HOSPITALIZATION FOR SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY, POLYARTHROPATHY. ADDITIONAL INFORMATION WAS RECEIVED ON 07-AUG-2017. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 7-AUG-2017: THE FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE PREVIOUS CASE ASSESSMENT. THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND LATER WAS HOSPITALIZED DUE TO SYSTEMIC INFLAMMATORY POLYARTHRITIS. SINCE SIGNIFICANT TEMPORAL RELATIONSHIP CAN BE ESTABLISHED CAUSAL ROLE OF SUSPECT PRODUCT IN OCCURRENCE OF THE EVENT CANNOT BE RULED OUT. HOWEVER, DUE TO LACK OF INFORMATION REGARDING MEDICAL HISTORY, UNDERLYING CONDITIONS, CONCOMITANT MEDICATIONS AND PAST DRUGS COMPLETE MEDICAL ASSESSMENT OF THE CASE IS DIFFICULT. ALSO, THE CAUSAL ROLE OF THE SUSPECT PRODUCT CANNOT BE ASSESSED IN THE CONTEXT OF OFF-LABEL USE.

    Description of Event or Problem · 1

    THIS UNSOLICITED LITERATURE CASE FROM UNITED STATES WAS RECEIVED FROM A CONFERENCE ABSTRACT: KOCAK D, ANNASWAMY T, CHONG S, ARORA R. DEVELOPMENT OF SYSTEMIC INFLAMMATORY POLYARTHRITIS AFTER ZYGAPOPHYSEAL JOINT INJECTION WITH HYLAN G-F 20 (SYNVISC-ONE). AM J PHYS MED REHABIL. 2017 JUL 13. DOI: 10.1097/ PHM.0000000000000797. THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO WAS INJECTED WITH SYNVISC ONE IN LUMBAR ZYGAPOPHYSEAL JOINT (OFF LABEL USE) AND LATER AFTER 2 DAYS EXPERIENCED SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. NO MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS REPORTED. ON AN UNKNOWN DATE, PATIENT RECEIVED TREATMENT WITH SYNVISC ONE INJECTION, AT A DOSE OF 6 ML, ONCE (ROUTE, INDICATION, LOT NUMBER AND EXPIRY DATE: NOT PROVIDED) IN LUMBAR ZYGAPOPHYSEAL JOINT (OFF LABEL USE). ON AN UNKNOWN DATE, 2 DAYS AFTER THE INJECTION, PATIENT HAD BILATERAL, DIFFUSE, JOINT PAIN AND SWELLING WITH ELEVATED INFLAMMATORY MARKERS SUGGESTIVE OF A SYSTEMIC INFLAMMATORY POLYARTHROPATHY THAT DEVELOPED ACUTELY 2 DAYS AFTER LUMBAR ZYGAPOPHYSEAL JOINT INJECTION WITH SYNVISC ONE. CORRECTIVE TREATMENT: NOT REPORTED FOR SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. OUTCOME: UNKNOWN FOR SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. REPORTER'S CAUSALITY: ADVERSE EFFECTS; THE MOST COMMON BEING LOCAL PAIN OR SWELLING. SERIOUSNESS CRITERIA: HOSPITALIZATION FOR SYSTEMIC INFLAMMATORY POLYARTHRITIS/ SYSTEMIC INFLAMMATORY POLYARTHROPATHY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(6) 2017: THIS CASE CONCERNS A PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE INJECTION AND LATER WAS HOSPITALIZED DUE TO SYSTEMIC INFLAMMATORY POLYARTHRITIS. SINCE SIGNIFICANT TEMPORAL RELATIONSHIP CAN BE ESTABLISHED CAUSAL ROLE OF SUSPECT PRODUCT IN OCCURRENCE OF THE EVENT CANNOT BE RULED OUT. HOWEVER, DUE TO LACK OF INFORMATION REGARDING MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND PAST DRUGS COMPLETE MEDICAL ASSESSMENT OF THE CASE IS DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565342 SYNVISC ONE MOZ MOZ GENZYME CORPORATION(RIDGEFIELD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R