BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 6098426 · Received November 14, 2016

    Report

    Report Number
    2246315-2016-00169
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 4, 2016
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON 4- NOV-2016 FROM PATIENT. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE IN HIPS (OFF LABEL USE) AND SINCE THEN PATIENT WAS UNABLE TO WALK/ DIFFICULTY WALKING, EXPERIENCED PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES) AND WERE SWOLLEN ON THE SAME DAY. NO CONCOMITANT MEDICATIONS, MEDICAL HISTORY OR CONCURRENT CONDITIONS WERE REPORTED. THE PATIENT HAD A HISTORY OF TREATMENT WITH SYNVISC-ONE, RECEIVING AN INJECTION TO EACH HIP AND ONE KNEE IN (B)(6) 2015 AND TO THE OTHER KNEE IN (B)(6) 2016. ON (B)(6) 2016, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, AT THE DOSE OF 6 ML ONCE (BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) IN BOTH THE HIPS FOR OSTEOARTHRITIS IN HIP. THE SAME DAY, PATIENT CLAIMED SHE WAS EXPERIENCING ENORMOUS AMOUNT OF PAIN, WAS UNABLE TO WALK AND WAS SWOLLEN AFTER RECEIVING THE INJECTION. ALSO, ON THE SAME DAY, PATIENT EXPERIENCED BIG PAIN (GROSSES DOULEURES) AND HAD DIFFICULTY WALKING AFTER RECEIVING THE INJECTION. AS OF (B)(6) 2016, BIG PAIN AND DIFFICULTY WALKING WERE ONGOING. ALSO THE PROCEDURE TO INJECT SYNVISC-ONE TO EACH HIP WAS GUIDED. CORRECTIVE TREATMENT: NOT REPORTED FOR UNABLE TO WALK/ DIFFICULTY WALKING; PARACETAMOL (TYLENOL) FOR PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES) AND SWOLLEN OUTCOME: NOT RECOVERED FOR UNABLE TO WALK/ DIFFICULTY WALKING; PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES) AND SWOLLEN. (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 MONITORED ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSED 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 WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. SERIOUSNESS CRITERION: PERSISTENT OR SIGNIFICANT DISABILITY / INCAPACITY ADDITIONAL INFORMATION WAS RECEIVED ON 04-NOV-2016 AND 07-NOV-2016 (BOTH THE INFORMATION WAS PROCESSED TOGETHER WITH COCK START DATE OF 04-NOV-2016) FROM PATIENT. PATIENT'S AGE AND PAST DRUG WAS ADDED. THE EVENT TERM UNABLE TO WALK WAS UPDATED TO UNABLE TO WALK/ DIFFICULTY WALKING AND PAIN IN BOTH HIPS WAS UPDATED TO PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES). GLOBAL PTC NUMBER AND RESULTS WERE ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 04-NOV-2016: THE ADDITIONAL INFORMATION DOES NOT ALTER THE PREVIOUS CASE ASSESSMENT. SANOFI COMPANY COMMENT DATED 09-NOV-2016: THIS CASE CONCERNS A PATIENT WHO RECEIVED SYNVISC ONE IN BOTH HIPS AND DEVELOPED PAIN AND SWELLING DUE TO WHICH SHE WAS UNABLE TO WALK WHICH LED TO SIGNIFICANT DISABILITY/INCAPACITY. BASED UPON THE REPORTED INFORMATION A CAUSAL ROLE OF PRODUCT FOR OCCURRENCE OF THESE EVENTS CANNOT BE DENIED AS THERE IS SIGNIFICANT PLAUSIBILITY THAT THE USE OF SYNVISC ONE LED TO DEVELOPMENT OF THESE EVENTS. ADVERSE REACTIONS INVOLVING PAIN AND SWELLING THE INJECTION SITE HAVE BEEN FREQUENTLY REPORTED AND WELL DOCUMENTED WITH USE OF SYNVISC ONE. THE ABASIA CAN BE ATTRIBUTED TO OCCURRENCE OF PAIN AND SWELLING. HOWEVER, SINCE THERE IS NO INFORMATION REGARDING TECHNIQUE USED FOR INJECTING THE PRODUCT, CONDITIONS UNDER WHICH PATIENT RECEIVED THE PRODUCT AND WHETHER PATIENT ADHERED TO POST INJECTION INSTRUCTIONS A COMPREHENSIVE CASE ASSESSMENT CANNOT BE MADE.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 10-NOV- 2016, THE CASE INITIALLY CONSIDERED AS SERIOUS WAS DOWNGRADED TO NON-SERIOUS SINCE THE SERIOUS EVENTS OF UNABLE TO WALK/ DIFFICULTY WALKING, PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES)/ENORMOUS AMOUNT OF PAIN AND SWOLLEN WERE RE-ASSESSED AS NON-SERIOUS. THIS UNSOLICITED CASE FROM (B)(6)WAS RECEIVED ON 4- NOV-2016 FROM PATIENT. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE IN HIPS (OFF LABEL USE) AND SINCE THEN PATIENT WAS UNABLE TO WALK/ DIFFICULTY WALKING, EXPERIENCED PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES) AND WERE SWOLLEN ON THE SAME DAY. NO CONCOMITANT MEDICATIONS, MEDICAL HISTORY OR CONCURRENT CONDITIONS WERE REPORTED. THE PATIENT HAD A HISTORY OF TREATMENT WITH SYNVISC-ONE, RECEIVING AN INJECTION TO EACH HIP AND ONE KNEE IN (B)(6) 2015 AND TO THE OTHER KNEE IN (B)(6) 2016. ON (B)(6) 2016, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, AT THE DOSE OF 6 ML ONCE (BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) IN BOTH THE HIPS FOR OSTEOARTHRITIS IN HIP. THE SAME DAY, PATIENT CLAIMED SHE WAS EXPERIENCING ENORMOUS AMOUNT OF PAIN, WAS UNABLE TO WALK AND WAS SWOLLEN AFTER RECEIVING THE INJECTION. ALSO, ON THE SAME DAY, PATIENT EXPERIENCED BIG PAIN (GROSSES DOULEURES) AND HAD DIFFICULTY WALKING AFTER RECEIVING THE INJECTION. AS OF (B)(6) 2016, BIG PAIN AND DIFFICULTY WALKING WERE ONGOING. ALSO THE PROCEDURE TO INJECT SYNVISC-ONE TO EACH HIP WAS GUIDED. CORRECTIVE TREATMENT: NOT REPORTED FOR UNABLE TO WALK/ DIFFICULTY WALKING; PARACETAMOL (TYLENOL) FOR PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES) AND SWOLLEN OUTCOME: NOT RECOVERED FOR UNABLE TO WALK/ DIFFICULTY WALKING; PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES) AND SWOLLEN A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (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 MONITORED ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESSED 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 WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 04-NOV-2016 AND 07-NOV-2016 (BOTH THE INFORMATION WAS PROCESSED TOGETHER WITH COCK START DATE OF (B)(6) 2016) FROM PATIENT. PATIENT'S AGE AND PAST DRUG WAS ADDED. THE EVENT TERM UNABLE TO WALK WAS UPDATED TO UNABLE TO WALK/ DIFFICULTY WALKING AND PAIN IN BOTH HIPS WAS UPDATED TO PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES). GLOBAL PTC NUMBER AND RESULTS WERE ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 10-NOV-2016, THE CASE INITIALLY CONSIDERED AS SERIOUS WAS DOWNGRADED TO NON-SERIOUS SINCE THE SERIOUS EVENTS OF UNABLE TO WALK/ DIFFICULTY WALKING, PAIN IN BOTH HIPS/ BIG PAIN (GROSSES DOULEURES)/ENORMOUS AMOUNT OF PAIN AND SWOLLEN WERE RE-ASSESSED AS NON-SERIOUS. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 10-NOV-2016: UPON RE-ASSESSING THE INITIAL INFORMATION RECEIVED FROM CONSUMER THE EVENTS WERE CONSIDERED AS NON-SERIOUS, THERE WAS NO EVIDENCE TO SUPPORT THE ASSESSMENT THAT THE EVENTS LED TO SIGNIFICANT OR PERSISTENT DISABILITY IN THE PATIENT. THUS THE BENEFIT/RISK PROFILE OF SYNVISC ONE REMAINS UNAFFECTED. SANOFI COMPANY COMMENT DATED 09-NOV-2016: THIS CASE CONCERNS A PATIENT WHO RECEIVED SYNVISC ONE IN BOTH HIPS AND DEVELOPED PAIN AND SWELLING DUE TO WHICH SHE WAS UNABLE TO WALK WHICH LED TO SIGNIFICANT DISABILITY/INCAPACITY. BASED UPON THE REPORTED INFORMATION A CAUSAL ROLE OF PRODUCT FOR OCCURRENCE OF THESE EVENTS CANNOT BE DENIED AS THERE IS SIGNIFICANT PLAUSIBILITY THAT THE USE OF SYNVISC ONE LED TO DEVELOPMENT OF THESE EVENTS. ADVERSE REACTIONS INVOLVING PAIN AND SWELLING THE INJECTION SITE HAVE BEEN FREQUENTLY REPORTED AND WELL DOCUMENTED WITH USE OF SYNVISC ONE. THE ABASIA CAN BE ATTRIBUTED TO OCCURRENCE OF PAIN AND SWELLING. HOWEVER, SINCE THERE IS NO INFORMATION REGARDING TECHNIQUE USED FOR INJECTING THE PRODUCT, CONDITIONS UNDER WHICH PATIENT RECEIVED THE PRODUCT AND WHETHER PATIENT ADHERED TO POST INJECTION INSTRUCTIONS A COMPREHENSIVE CASE ASSESSMENT CANNOT BE MADE.

    Description of Event or Problem · 1

    THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON 4- NOV-2016 FROM PATIENT. THIS CASE INVOLVES AN ADULT FEMALE PATIENT (AGE UNSPECIFIED) WHO RECEIVED TREATMENT WITH SYNVISC ONE IN HIPS (OFF LABEL USE) AND SINCE THEN PATIENT WAS UNABLE TO WALK, PAIN IN BOTH HIPS AND SWOLLEN. NO CONCOMITANT MEDICATIONS, PAST DRUGS, MEDICAL HISTORY OR CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2016, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, AT THE DOSE OF 6 ML ONCE (BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) IN BOTH THE HIPS FOR OSTEOARTHRITIS. THE SAME DAY, PATIENT CLAIMED SHE WAS EXPERIENCING ENORMOUS AMOUNT OF PAIN, WAS UNABLE TO WALK AND WAS SWOLLEN AFTER RECEIVING THE INJECTION. CORRECTIVE TREATMENT: NOT REPORTED FOR UNABLE TO WALK; PARACETAMOL (TYLENOL) FOR PAIN IN BOTH HIPS AND SWOLLEN. OUTCOME: NOT RECOVERED FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. SERIOUSNESS CRITERION: PERSISTENT OR SIGNIFICANT DISABILITY / INCAPACITY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 09-NOV-2016: THIS CASE CONCERNS A PATIENT WHO RECEIVED SYNVISC ONE IN BOTH HIPS AND DEVELOPED PAIN AND SWELLING DUE TO WHICH SHE WAS UNABLE TO WALK WHICH LED TO SIGNIFICANT DISABILITY/ INCAPACITY. BASED UPON THE REPORTED INFORMATION, A CAUSAL ROLE OF PRODUCT FOR OCCURRENCE OF THESE EVENTS CANNOT BE DENIED AS THERE IS SIGNIFICANT PLAUSIBILITY THAT THE USE OF SYNVISC ONE LED TO DEVELOPMENT OF THESE EVENTS. ADVERSE REACTIONS INVOLVING PAIN AND SWELLING THE INJECTION SITE HAVE BEEN FREQUENTLY REPORTED AND WELL DOCUMENTED WITH USE OF SYNVISC ONE. THE ABASIA CAN BE ATTRIBUTED TO OCCURRENCE OF PAIN AND SWELLING. HOWEVER, SINCE THERE IS NO INFORMATION REGARDING TECHNIQUE USED FOR INJECTING THE PRODUCT, CONDITIONS UNDER WHICH PATIENT RECEIVED THE PRODUCT AND WHETHER PATIENT ADHERED TO POST INJECTION INSTRUCTIONS A COMPREHENSIVE CASE ASSESSMENT CANNOT BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751759 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability