BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNVISC

    MDR report key: 6046223 · Received October 21, 2016

    Report

    Report Number
    2246315-2016-00159
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    June 10, 2016
    Report Date
    July 25, 2016
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    MOZ
    PMA / PMN Number
    P940015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 25-JAN-2017 FROM THE PHYSICIAN, THIS CASE BECAME MEDICALLY CONFIRMED. BASED ON ADDITIONAL INFORMATION RECEIVED ON 13-OCT- 2016, THIS CASE PREVIOUSLY CONSIDERED AS NON-VALID BECAME VALID BECAUSE THE EVENT OF TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS ADDED. THIS CASE IS CROSS REFERENCED WITH CASE ID'S: (B)(6). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 25-JUL-2016 FROM A NON-HEALTH CARE PROFESSIONAL. THIS CASE CONCERN A (B)(6) PATIENT (WITH UNSPECIFIED GENDER) WHO RECEIVED TREATMENT WITH SYNVISC INJECTION AND AFTER 7 DAYS OF STARTING TREATMENT EXPERIENCED SEVERE INFLAMMATION OF KNEE. THE PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION, PAST DRUGS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2016, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION, WEEKLY (DOSE: NOT REPORTED; LOT/BATCH NUMBER: 5RSA022ZA AND EXPIRATION DATE: 30-SEP-2018 FOR BOTH INJECTIONS) FOR DEGENERATIVE ARTHRITIS OF KNEE. ON (B)(6) 2016, 7 DAYS AFTER STARTING TREATMENT, THE PATIENT HAD SEVERE INFLAMMATION OF KNEES. THE SAME DAY, THE PATIENT RECEIVED THE LAST DOSE OF SYNVISC. IT WAS REPORTED THAT ARTHROCENTESIS WAS PERFORMED AND 45 CC OF STRAW COLORED FLUID WAS WITHDRAWN. ON (B)(6) 2016, SYNOVIAL FLUID CULTURE WAS PERFORMED WHICH CAME OUT TO BE NEGATIVE. IT WAS REPORTED THAT THE KNEE WAS INJECTED WITH LOT OF TRIAMCINOLONE ACETONIDE (KENALOG) AT A DOSE OF 40 MG/CC. ALSO REPORTED, INFLAMMATION RESOLVED BUT THE JOINT EFFUSION WAS ONGOING. ACTION TAKEN: PERMANENTLY DISCONTINUED. CORRECTIVE TREATMENT: ARTHROCENTESIS, TRIAMCINOLONE ACETONIDE. OUTCOME: RECOVERING. SERIOUSNESS CRITERION: REQUIRED INTERVENTION. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # 5RSA022ZA EXPIRATION DATE (09/2018) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT # BATCH RECORD REVIEW & LOT # FREQUENCY ANALYSIS FOR LOT # 5RSA022ZA NO CAPA WAS REQUIRED. SANOFI GENZYME 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. AS OF 02-AUG -16, THERE WERE A TOTAL OF 5 COMPLAINTS ON FILE FOR LOT #5RSA022 AND ALL RELATED SUB-LOTS. THERE WERE 2 COMPLAINTS ON FILE FOR LOT #5RSA022ZA: (1) ADVERSE EVENT REPORT AND (1) (2 BARREL BREAKAGES/1 BROKEN FINGER FLANGE). THERE WERE 3 COMPLAINTS FOR LOT #5RSA022: (1) BROKEN LUER-LOK HUB AND (2) ADVERSE EVENT REPORTS. SANOFI WILL CONTINUE TO MONITOR COMPLAINTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 02-AUG-2016. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 13-OCT-2016. THIS CASE PREVIOUSLY CONSIDERED AS NON-VALID BECAME VALID BECAUSE THE EVENT OF TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS ADDED. RELATED CASE ID WAS ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 01-NOV-2016. RELATED CASE ID WAS ADDED. TEXT WAS AMENDED ACCORDINGLY. FOLLOW UP WAS RECEIVED ON 07-NOV-2016. NO NEW INFORMATION WAS RECEIVED. FOLLOW UP WAS RECEIVED ON 11-NOV-2016. CROSS REFERENCED CASE ID ((B)(6)) WAS ADDED. NON-SIGNIFICANT INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2016. EVENT OUTCOME WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 25-JAN-2017 FROM THE PHYSICIAN AND THE CASE BECAME MEDICALLY CONFIRMED. THE EVENT OF A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS UPDATED TO SEVERE INFLAMMATION OF KNEE ALONG WITH THE DETAILS AND JOINT EFFUSION WAS CAPTURED AS ITS SYMPTOM. CORRECTIVE TREATMENT AND LABORATORY DATA WAS ADDED. THE OUTCOME FOR THE EVENT WAS UPDATED FROM RECOVERED TO RECOVERING. THE PRODUCT START DATE, FREQUENCY AND INDICATION WAS UPDATED. ACTION TAKEN WAS UPDATED FROM UNKNOWN TO PERMANENTLY DISCONTINUED. THE NUMBER OF PATIENTS IN THE CASE WERE UPDATED FROM 2 TO 1 AND RELATED CASE ID ((B)(6)) WAS ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 13-OCT- 2016, THIS CASE PREVIOUSLY CONSIDERED AS NON-VALID BECAME VALID BECAUSE THE EVENT OF TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS ADDED. THIS CASE IS CROSS REFERENCED WITH CASE ID'S: (B)(4) (CLUSTER) AND (B)(4) (DUPLICATE). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 25-JUL-2016 FROM A NON-HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS TWO PATIENTS (DEMOGRAPHICS NOT PROVIDED) WHO RECEIVED TREATMENT WITH SYNVISC INJECTION AND AFTER AN UNKNOWN LATENCY UNKNOWN, TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE THE PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION, PAST DRUGS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON UNKNOWN DATES, THE PATIENTS INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (INDICATION, DOSE, FREQUENCY: NOT REPORTED; LOT/BATCH NUMBER: 5RSA022ZA AND EXPIRATION DATE: 30-SEP-2018 FOR BOTH INJECTIONS). ON UNSPECIFIED DATES, AFTER UNKNOWN LATENCIES, BOTH PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD UP AROUND THE KNEE THAT RESULTED IN TWO HOSPITALIZATIONS. ACTION TAKEN: UNKNOWN; CORRECTIVE TREATMENT: NOT REPORTED; OUTCOME: UNKNOWN; SERIOUSNESS CRITERION: HOSPITALIZATION; A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # 5RSA022ZA EXPIRATION DATE (09/2018) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT # BATCH RECORD REVIEW & LOT # FREQUENCY ANALYSIS FOR LOT # 5RSA022ZA NO CAPA WAS REQUIRED. SANOFI GENZYME 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. AS OF 02-AUG -16, THERE WERE A TOTAL OF (B)(4) COMPLAINTS ON FILE FOR LOT# 5RSA022 AND ALL RELATED SUB-LOTS. THERE ARE 2 COMPLAINTS ON FILE FOR LOT# 5RSA022ZA: (1) ADVERSE EVENT REPORT AND (1) (2 BARREL BREAKAGES/1 BROKEN FINGER FLANGE). THERE ARE (B)(4) COMPLAINTS FOR LOT #5RSA022: (1) BROKEN LUER-LOK HUB AND (2) ADVERSE EVENT REPORTS. SANOFI WILL CONTINUE TO MONITOR COMPLAINTS TO DETERMINE IF A CAPA IS REQUIRED. SERIOUSNESS CRITERIA: HOSPITALIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 02-AUG-2016. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 13-OCT-2016. THIS CASE PREVIOUSLY CONSIDERED AS NON-VALID BECAME VALID BECAUSE THE EVENT OF TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS ADDED. RELATED CASE ID WAS ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY.

    Description of Event or Problem · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED ON 13-OCT- 2016, THIS CASE PREVIOUSLY CONSIDERED AS NON-VALID BECAME VALID BECAUSE THE EVENT OF TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS ADDED. THIS CASE IS CROSS REFERENCED WITH CASE ID'S: (B)(4) (CLUSTER) AND (B)(4) (DUPLICATE). THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 25-JUL-2016 FROM A NON-HEALTH CARE PROFESSIONAL. THIS CASE CONCERNS TWO PATIENTS (DEMOGRAPHICS NOT PROVIDED) WHO RECEIVED TREATMENT WITH SYNVISC INJECTION AND AFTER AN UNKNOWN LATENCY UNKNOWN, TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE. THE PATIENT'S MEDICAL HISTORY, CONCURRENT CONDITION, PAST DRUGS AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON UNKNOWN DATES, THE PATIENTS INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (INDICATION, DOSE, FREQUENCY: NOT REPORTED; LOT/BATCH NUMBER: 5RSA022ZA AND EXPIRATION DATE: 30-SEP-2018 FOR BOTH INJECTIONS). ON UNSPECIFIED DATES, AFTER UNKNOWN LATENCIES, BOTH PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD UP AROUND THE KNEE THAT RESULTED IN TWO HOSPITALIZATIONS. ON AN UNKNOWN DATE, THE PATIENTS RECOVERED FROM THE EVENT. IT WAS REPORTED THAT THE PATIENTS WERE APPROVED FOR REPLACEMENT. ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED/ RESOLVED. SERIOUSNESS CRITERION: HOSPITALIZATION. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (B)(4). THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT # 5RSA022ZA EXPIRATION DATE (09/2018) WAS REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. BASED ON THE LOT # BATCH RECORD REVIEW & LOT # FREQUENCY ANALYSIS FOR LOT # 5RSA022ZA NO CAPA WAS REQUIRED. SANOFI GENZYME 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. AS OF 02-AUG -2016, THERE WERE A TOTAL OF 5 COMPLAINTS ON FILE FOR LOT# 5RSA022 AND ALL RELATED SUB-LOTS. THERE ARE 2 COMPLAINTS ON FILE FOR LOT# 5RSA022ZA: (1) ADVERSE EVENT REPORT AND (1) (2 BARREL BREAKAGES/1 BROKEN FINGER FLANGE). THERE ARE 3 COMPLAINTS FOR LOT #5RSA022: (1) BROKEN LUER-LOK HUB AND (2) ADVERSE EVENT REPORTS. SANOFI WILL CONTINUE TO MONITOR COMPLAINTS TO DETERMINE IF A CAPA WAS REQUIRED. SERIOUSNESS CRITERIA: HOSPITALIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 02-AUG-2016. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 13-OCT-2016. THIS CASE PREVIOUSLY CONSIDERED AS NON-VALID BECAME VALID BECAUSE THE EVENT OF TWO PATIENTS EXPERIENCED A LARGE AMOUNT OF FLUID BUILD-UP AROUND THE KNEE WAS ADDED. RELATED CASE ID WAS ADDED. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 01-NOV-2016. RELATED CASE ID WAS ADDED. TEXT WAS AMENDED ACCORDINGLY. FOLLOW UP WAS RECEIVED ON 07-NOV-2016. NO NEW INFORMATION WAS RECEIVED. FOLLOW UP WAS RECEIVED ON 11-NOV-2016. CROSS REFERENCED CASE ID ((B)(4)) WAS ADDED. NON-SIGNIFICANT INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2016. EVENT OUTCOME WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698930 SYNVISC INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) 5RSA022ZA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R