SYNVISC ONE (SYNVISC ONE)
Report
- Report Number
- 2246315-2016-00177
- Event Type
- Injury
- Date Received
- November 24, 2016
- Date of Event
- September 27, 2016
- Report Date
- October 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
- PHYSICIAN
Narratives
BASED ON ADDITIONAL INFORMATION RECEIVED ON 16-NOV-2016 FROM A PHYSICIAN, THE CASE WAS MEDICALLY CONFIRMED. ALSO THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE EVENTS SWELLING IN LEFT KNEE, FROZE HER KNEE TO EXTRACT THE WATER FROM IT AND LEFT KNEE PAIN WERE UPDATED TO SERIOUS WITH REQUIRED INTERVENTION AS SERIOUSNESS CRITERIA. THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2016 FROM A PATIENT. THIS CASE INVOLVES A (B)(6) FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND THE SAME DAY HAD SWELLING IN LEFT KNEE, AFTER 24 HOURS FROZE HER KNEE TO EXTRACT THE WATER FROM IT AND HAD LEFT KNEE PAIN. NO MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE REPORTED. PREVIOUS MEDICATION INCLUDED SYNVISC INJECTIONS (FOR MANY YEARS). ON (B)(6) 2016, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONE INJECTION, AT A DOSE OF 6 ML ONCE, IN THE MORNING (BATCH/LOT NUMBER AND EXPIRATION DATE: UNKNOWN) IN HER LEFT KNEE FOR OSTEOARTHRITIS AND TORN LIGAMENT. THE SAME DAY, BY THE AFTERNOON, THE SEVERE SWELLING IN HER KNEE BEGAN. WHEN SHE RETURNED HOME, HER KNEE WAS SWOLLEN. ON AN UNKNOWN DATE IN (B)(6) 2016, 24 HOURS AFTER RECEIVING THE INJECTION, PATIENT EXPERIENCED SEVERE LEFT KNEE PAIN. AS A CORRECTIVE TREATMENT, THE PATIENT PUT ICE ON IT, TOOK 100 MG OF CELECOXIB ((B)(6)) AND PUT A COLD COMPRESS FOR PAIN RELIEF, WHICH REDUCED THE SWELLING. HOWEVER, THE SWELLING IN HER KNEE RETURNED THE FOLLOWING DAY BUT IT WAS LESS SWOLLEN. ON AN UNKNOWN DATE IN (B)(6) 2016, 24 HOURS AFTER RECEIVING THE INJECTION, PATIENT HAD SEVERE JOINT EFFUSION. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2016 (SAW A DIFFERENT DOCTOR), AND THE PHYSICIAN FROZE HER KNEE TO EXTRACT THE WATER FROM IT (INTENSITY: SEVERE). KNEE PUNCTION WAS DONE AND 80 CC FLUID WAS DRAINED OUT. ALSO PATIENT RECEIVED A CORTISONE INJECTION AND WAS EVALUATED FOR INFECTIONS WORK UP. IT WAS REPORTED THAT THE EVENTS WERE NOT RELATED TO PATIENT'S PRE-EXISTING CONDITION. ON (B)(6) 2016, THE PATIENT WAS RECOVERED. THE PATIENT HAD A FOLLOW UP APPOINTMENT ON THE SAME DAY. CORRECTIVE TREATMENT: CELECOXIB, COLD COMPRESS; ICE, CORTISONE INJECTION, KNEE PUNCTION MORE THAN 80 CC FOR ALL EVENTS OUTCOME: RECOVERED FOR ALL 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 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. REPORTER'S CAUSALITY: RELATED FOR ALL EVENTS. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR ALL EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 04-OCT-2016. PATIENT'S AGE WAS ADDED. PAST USE OF SYNVISC WAS ADDED. OUTCOME OF SWELLING IN LEFT KNEE WAS UPDATED FROM UNKNOWN TO RECOVERED/ RESOLVED AND IT'S CORRECTIVE TREATMENT WAS UPDATED. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 10-OCT-2016. GLOBAL PTC NUMBER AND RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2016 FROM A PHYSICIAN. THE CASE WAS UPGRADED TO SERIOUS AND WAS MEDICALLY CONFIRMED. OUTCOME OF FROZE HER KNEE TO EXTRACT THE WATER FROM IT WAS UPDATED FROM UNKNOWN TO RECOVERED. RECOVERY DATES OF ALL EVENTS WERE UPDATED TO (B)(6) 2016. KNEE PUNCTION AND CORTISONE WAS ADDED AS CORRECTIVE TREATMENT FOR ALL EVENTS. INTENSITY OF ALL EVENTS WAS ADDED. LOT NUMBER OF SYNVISC ONE WAS ADDED. REPORTER'S CAUSALITY AND SERIOUSNESS CRITERIA WAS ADDED. LABORATORY TEST WAS ADDED. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY. FOLLOW UP INFORMATION WAS RECEIVED ON 02-DEC-2016. INVESTIGATION SUMMARY RECEIVED WITHOUT LOT/ BATCH NUMBER, HENCE NOT PROCESSED IN THE CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-DEC-2016. THE LOT/BATCH NUMBER OF THE SUSPECT WAS REMOVED AND THE INVESTIGATION RESULTS RECEIVED WITHOUT THE LOT/BATCH NUMBER WAS PROCESSED. TEXT AMENDED ACCORDINGLY.
BASED ON ADDITIONAL INFORMATION RECEIVED ON 16-NOV-2016 FROM A PHYSICIAN, THE CASE WAS MEDICALLY CONFIRMED. ALSO THIS CASE INITIALLY CONSIDERED AS NON-SERIOUS WAS UPGRADED TO SERIOUS AS THE EVENTS SWELLING IN LEFT KNEE, FROZE HER KNEE TO EXTRACT THE WATER FROM IT AND LEFT KNEE PAIN WERE UPDATED TO SERIOUS WITH REQUIRED INTERVENTION AS SERIOUSNESS CRITERIA. THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2016 FROM A PATIENT. THIS CASE INVOLVES A (B)(6) YEARS OLD FEMALE PATIENT WHO RECEIVED TREATMENT WITH SYNVISC ONE AND THE SAME DAY HAD SWELLING IN LEFT KNEE, AFTER 24 HOURS FROZE HER KNEE TO EXTRACT THE WATER FROM IT AND HAD LEFT KNEE PAIN. NO MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE REPORTED. PREVIOUS MEDICATION INCLUDED SYNVISC INJECTIONS (FOR MANY YEARS). ON (B)(6) 2016, THE PATIENT RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE INJECTION, ONE INJECTION, AT A DOSE OF 6 ML ONCE, IN THE MORNING (BATCH/LOT NUMBER: 009C8014 AND EXPIRATION DATE: NOT PROVIDED) IN HER LEFT KNEE FOR OSTEOARTHRITIS AND TORN LIGAMENT. THE SAME DAY, BY THE AFTERNOON, THE SEVERE SWELLING IN HER KNEE BEGAN. WHEN SHE RETURNED HOME, HER KNEE WAS SWOLLEN. ON AN UNKNOWN DATE IN (B)(6) 2016, 24 HOURS AFTER RECEIVING THE INJECTION, PATIENT EXPERIENCED SEVERE LEFT KNEE PAIN. AS A CORRECTIVE TREATMENT, THE PATIENT PUT ICE ON IT, TOOK 100 MG OF CELECOXIB (CELEBREX) AND PUT A COLD COMPRESS FOR PAIN RELIEF, WHICH REDUCED THE SWELLING. HOWEVER, THE SWELLING IN HER KNEE RETURNED THE FOLLOWING DAY BUT IT WAS LESS SWOLLEN. ON AN UNKNOWN DATE IN (B)(6) 2016, 24 HOURS AFTER RECEIVING THE INJECTION, PATIENT HAD SEVERE JOINT EFFUSION. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2016 (SAW A DIFFERENT DOCTOR), AND THE PHYSICIAN FROZE HER KNEE TO EXTRACT THE WATER FROM IT (INTENSITY: SEVERE). KNEE PUNCTION WAS DONE AND 80 CC FLUID WAS DRAINED OUT. ALSO PATIENT RECEIVED A CORTISONE INJECTION AND WAS EVALUATED FOR INFECTIONS WORK UP. IT WAS REPORTED THAT THE EVENTS WERE NOT RELATED TO PATIENT'S PRE-EXISTING CONDITION. ON (B)(6) 2016, THE PATIENT WAS RECOVERED. THE PATIENT HAD A FOLLOW UP APPOINTMENT ON THE SAME DAY. CORRECTIVE TREATMENT: CELECOXIB, COLD COMPRESS; ICE, CORTISONE INJECTION, KNEE PUNCTION MORE THAN 80 CC FOR ALL EVENTS. OUTCOME: RECOVERED FOR ALL 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 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. REPORTER'S CAUSALITY: RELATED FOR ALL EVENTS. SERIOUSNESS CRITERIA: REQUIRED INTERVENTION FOR ALL EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 04-OCT-2016. PATIENT'S AGE WAS ADDED. PAST USE OF SYNVISC WAS ADDED. OUTCOME OF SWELLING IN LEFT KNEE WAS UPDATED FROM UNKNOWN TO RECOVERED/ RESOLVED AND IT'S CORRECTIVE TREATMENT WAS UPDATED. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 10-OCT-2016. GLOBAL PTC NUMBER AND RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016 FROM A PHYSICIAN. THE CASE WAS UPGRADED TO SERIOUS AND WAS MEDICALLY CONFIRMED. OUTCOME OF FROZE HER KNEE TO EXTRACT THE WATER FROM IT WAS UPDATED FROM UNKNOWN TO RECOVERED. RECOVERY DATES OF ALL EVENTS WERE UPDATED FROM (B)(6) 2016. KNEE PUNCTION AND CORTISONE WAS ADDED AS CORRECTIVE TREATMENT FOR ALL EVENTS. INTENSITY OF ALL EVENTS WAS ADDED. LOT NUMBER OF SYNVISC ONE WAS ADDED. REPORTER'S CAUSALITY AND SERIOUSNESS CRITERIA WAS ADDED. LABORATORY TEST WAS ADDED. CLINICAL COURSE WAS UPDATED. TEXT WAS AMENDED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777811 | SYNVISC ONE (SYNVISC ONE) | INTRA-ARTICULAR HYALURONIC ACID | MOZ | GENZYME BIOSURGERY (RIDGEFIELD) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | SYNVISC (PREV.) |