BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC ONE (SYNVISC ONE)

    MDR report key: 5252356 · Received November 26, 2015

    Report

    Report Number
    2246315-2015-98601
    Event Type
    Injury
    Date Received
    November 26, 2015
    Date of Event
    July 11, 2015
    Report Date
    September 24, 2015
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 19-NOV- 2015, THIS CASE INITIALLY ASSESSED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE SERIOUS EVENT OF INJECTION SITE INFLAMMATION WAS ADDED TO THE CASE. THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A HEALTH PROFESSIONAL/ PHYSICIAN. THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND LATER DEVELOPED INJECTION SITE EDEMA, C REACTIVE PROTEIN AT 109 MG/L, SEDIMENTATION RATE AT 35 MM, INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, PHLEBITIS, CHILLS AND PATIENT DID NOT MANAGE TO SLEEP. THE PATIENT'S MEDICAL HISTORY INCLUDED KNEE OSTEOARTHRITIS OR METABOLIC RHEUMATISM, RECURRENT HYDRARTHROSIS SINCE 2012. PATIENT HAD ARTHROSIS SINCE 2010 AND WAS TREATED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AND CORTICOIDS NOS. CONCURRENT CONDITION INCLUDED KNEE EDEMA. RELEVANT CONCOMITANT MEDICATION INCLUDED CORTIVAZOL (ALTIM) AND DICLOFENAC SODIUM (VOLTARENE) FOR ARTHROSIS. ON (B)(6) 2015, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (DOSE, BATCH/LOT NUMBER AND EXPIRATION: NOT PROVIDED) IN UNSPECIFIED JOINT OF KNEE FOR KNEE OSTEOARTHRITIS. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY RECEIVED A SYNVISC ONE INJECTION ON AN UNSPECIFIED DATE WITH A GOOD TOLERANCE. ON (B)(6) 2015, 12 DAYS AFTER RECEIVING TREATMENT WITH SYNVISC ONE, THE PATIENT PRESENTED WITH AN SEVERE INJECTION SITE INFLAMMATION, EFFUSION OF RIGHT AND LEFT KNEE, PAIN, REDNESS AND CHILLS. ON (B)(6) 2015, PATIENT HAD ARTHROSCOPY, INTRA-ARTICULAR LAVAGE AND SYNOVECTOMY. PUNCTION SHOWED STERILE LIQUID. IT WAS REPORTED THAT THE PATIENT HAD NO INTENSE PHYSICAL ACTIVITY AFTER THE INJECTION. ON AN UNKNOWN DATE IN (B)(6) 2015, THE PATIENT DID NOT MANAGE TO SLEEP. ON (B)(6) 2015, 31 DAYS AFTER RECEIVING FIRST SYNVISC ONE INJECTION, PATIENT PRESENTED WITH SEVERE PHLEBITIS. ON UNKNOWN DATES, THE C-REACTIVE PROTEIN WAS 109 MG/L AND SEDIMENTATION RATE WAS 35 MINUTES. IT WAS REPORTED THAT THERE WAS NO SEPSIS. CORRECTIVE TREATMENT: ARTHROSCOPY, INTRA-ARTICULAR LAVAGE AND SYNOVECTOMY FOR INJECTION SITE INFLAMMATION AND PAIN, NOT REPORTED FOR OTHER EVENTS OUTCOME: RECOVERED/ RESOLVED WITH SEQUELAE FOR INJECTION SITE INFLAMMATION, RECOVERED FOR CHILLS AND UNKNOWN FOR REST OF THE EVENTS. 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 IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. GENZYME 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. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. REPORTER'S CAUSALITY: PROBABLY RELATED (B)(6) IMPUTABILITY: (B)(4) FOR INJECTION SITE INFLAMMATION AND (B)(4) FOR OTHER EVENTS. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR INJECTION SITE INFLAMMATION ADDITIONAL INFORMATION WAS RECEIVED ON 01-OCT-2015. PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 19-NOV-2015. ADDITIONAL EVENTS OF INJECTION SITE INFLAMMATION, PHLEBITIS AND CHILLS WERE ADDED ALONG WITH DETAILS. INDICATION OF SYNVISC ONE WAS UPDATED FROM KNEE OEDEMA TO KNEE OSTEOARTHRITIS. PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION AND CONCOMITANT MEDICATION WERE ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 01-DEC-2015. PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 19-NOV- 2015, THIS CASE INITIALLY ASSESSED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE SERIOUS EVENT OF INJECTION SITE INFLAMMATION WAS ADDED TO THE CASE. THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A HEALTH PROFESSIONAL/ PHYSICIAN. THIS CASE CONCERNS A (B)(6) YEAR OLD MALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND LATER DEVELOPED INJECTION SITE EDEMA, C REACTIVE PROTEIN AT 109 MG/L, SEDIMENTATION RATE AT 35 MM, INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, PHLEBITIS, CHILLS AND PATIENT DID NOT MANAGE TO SLEEP. THE PATIENT'S MEDICAL HISTORY INCLUDED KNEE OSTEOARTHRITIS OR METABOLIC RHEUMATISM, RECURRENT HYDRARTHROSIS SINCE 2012. PATIENT HAD ARTHROSIS SINCE 2010 AND WAS TREATED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AND CORTICOIDS NOS. CONCURRENT CONDITION INCLUDED KNEE EDEMA. RELEVANT CONCOMITANT MEDICATION INCLUDED CORTIVAZOL (ALTIM) AND DICLOFENAC SODIUM (VOLTARENE) FOR ARTHROSIS. ON (B)(6) 2015, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONCE (DOSE, BATCH/LOT NUMBER AND EXPIRATION: NOT PROVIDED) IN UNSPECIFIED JOINT OF KNEE FOR KNEE OSTEOARTHRITIS. IT WAS REPORTED THAT THE PATIENT PREVIOUSLY RECEIVED A SYNVISC ONE INJECTION ON AN UNSPECIFIED DATE WITH A GOOD TOLERANCE. ON (B)(6) 2015, 12 DAYS AFTER RECEIVING TREATMENT WITH SYNVISC ONE, THE PATIENT PRESENTED WITH AN SEVERE INJECTION SITE INFLAMMATION, EFFUSION OF RIGHT AND LEFT KNEE, PAIN, REDNESS AND CHILLS. ON (B)(6) 2015, PATIENT HAD ARTHROSCOPY, INTRA-ARTICULAR LAVAGE AND SYNOVECTOMY. PUNCTION SHOWED STERILE LIQUID. IT WAS REPORTED THAT THE PATIENT HAD NO INTENSE PHYSICAL ACTIVITY AFTER THE INJECTION. ON AN UNKNOWN DATE IN (B)(6) 2015, THE PATIENT DID NOT MANAGE TO SLEEP. ON (B)(6) 2015, 31 DAYS AFTER RECEIVING FIRST SYNVISC ONE INJECTION, PATIENT PRESENTED WITH SEVERE PHLEBITIS. ON UNKNOWN DATES, THE C-REACTIVE PROTEIN WAS 109 MG/L AND SEDIMENTATION RATE WAS 35 MINUTES. IT WAS REPORTED THAT THERE WAS NO SEPSIS. CORRECTIVE TREATMENT: ARTHROSCOPY, INTRA-ARTICULAR LAVAGE AND SYNOVECTOMY FOR INJECTION SITE INFLAMMATION AND PAIN, NOT REPORTED FOR OTHER EVENTS. OUTCOME: RECOVERED/ RESOLVED WITH SEQUELAE FOR INJECTION SITE INFLAMMATION, RECOVERED FOR CHILLS AND UNKNOWN FOR REST OF THE EVENTS. 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 IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. GENZYME 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. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA IS REQUIRED. REPORTER'S CAUSALITY: PROBABLY RELATED. (B)(4) IMPUTABILITY: FOR INJECTION SITE INFLAMMATION AND (B)(4) FOR OTHER EVENTS. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR INJECTION SITE INFLAMMATION. ADDITIONAL INFORMATION WAS RECEIVED ON 01-OCT-2015. PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 19-NOV-2015. ADDITIONAL EVENTS OF INJECTION SITE INFLAMMATION, PHLEBITIS AND CHILLS WERE ADDED ALONG WITH DETAILS. INDICATION OF SYNVISC ONE WAS UPDATED FROM KNEE OEDEMA TO KNEE OSTEOARTHRITIS. PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION AND CONCOMITANT MEDICATION WERE ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782455 SYNVISC ONE (SYNVISC ONE) INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention