SYNVISC ONE
Report
- Report Number
- 2246315-2019-00037
- Event Type
- Injury
- Date Received
- February 12, 2019
- Date of Event
- August 23, 2018
- Report Date
- March 22, 2019
- Manufacturer
- GENZYME CORPORATION(RIDGEFIELD)
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
COULD NOT WALK [UNABLE TO WALK] . LEFT TOTAL KNEE ARTHROPLASTY [KNEE ARTHROPLASTY]. LEFT KNEE SWELLED [INJECTION SITE JOINT SWELLING]. NERVOUSNESS [NERVOUSNESS] . UPPER RESPIRATORY INFECTION [UPPER RESPIRATORY INFECTION] . LEFT MEDIAL JOINT LINE TENDERNESS [INJECTION SITE JOINT TENDERNESS] . LEFT KNEE EFFUSION [KNEE EFFUSION]. CASE NARRATIVE: THIS CASE IS CROSS-REFERENCED TO (B)(4). INITIAL INFORMATION RECEIVED ON 23-JAN-2019 FROM UNITED STATES REGARDING AN UNSOLICITED VALID LEGAL SERIOUS CASE RECEIVED FROM LAWYER. THIS CASE INVOLVES A 56 YEARS OLD FEMALE PATIENT WHO EXPERIENCED COUD NOT WALK, LEFT KNEE SWELLED, LEFT TOTAL KNEE ARTHROPLASTY, NERVOUSNESS, LEFT MEDIAL JOINT LINE TENDERNESS AND LEFT KNEE EFFUSION, UPPER RESPIRATORY INFECTION WHILE SHE WAS TREATED WITH MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC ONE). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ARTHRITIS WITH RECEIVED STERIOD AND GEL INJECTIONS, GASTROINTESTINAL HAEMORRHAGE, NEPHROLITHIASIS, PULMONARY MASS, COLONOSCOPY, POLYPECTOMY, ARTHRALGIA, INJECTION SITE JOINT DISCOMFORT, JOINT STIFFNESS, DEPRESSION, DIVERTICULUM, ANXIETY, LT KNEE SCOPE, PMM, MFC AND PATELLA CHONDROPLASTY AND LOOSE BODY REMOVED LEUKOCYTOSIS, JOINT INSTABILITY, INJURY, NEPHROLITHIASIS, MENISCUS REMOVAL AND JOINT LOCK. THE PATIENT'S PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING GAIT DISTURBANCE AND NON-TOBACCO USER. CONCOMITANT MEDICATIONS INCLUDED OXYCODONE; FLUOXETINE HYDROCHLORIDE (PROZAC); ZOLPIDEM TARTRATE (AMBIEN); IBUPROFEN (IBUPROFEN); AND TRAMADOL HCL (TRAMADOL HCL), VITAMIN D3 50000, GABAPENTIN, BENTYL, NAPROXEN, FLONASE ALLERGY RELIEF. ON 23-AUG-2018, THE PATIENT STARTED USING HYLAN G-F 20, SODIUM HYALURONATE INJECTION IN LEFT KNEE VIA INTRA-ARTICULAR ROUTE, DOSAGE UNKNOWN, ONCE (LOT - UNK) FOR OSTEOARTHRITIS WHICH THE PATIENT TOLERATED WITHOUT ADVERSE REACTIONS OR COMPLICATIONS. ON THE SAME DAY IN THE EVENING, THE PATIENT DEVELOPED AN EVENT OF A SERIOUS COUD NOT WALK (GAIT INABILITY), LEFT KNEE SWELLED (JOINT SWELLING) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE PATIENT PRESENTED TO THE PHYSICIAN USING CRUTCHES AND WEARING ACE BANDAGES. THE PATIENT REPORTED THAT EVENING AFTER THE INJECTION, BOTH KNEES SWELLED TO THE POINT THAT SHE COULD NOT WALK AND THE PHYSICIAN HAS TO ASPIRATE THE KNEE. ON (B)(6) 2018, THE PATIENT HAD LEFT TOTAL KNEE ARTHROPLASTY (KNEE ARTHROPLASTY) AFTER USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN EVENT OF A NON-SERIOUS NERVOUSNESS, LEFT MEDIAL JOINT LINE TENDERNESS (INJECTION SITE JOINT PAIN) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE SURGERY FOR LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 USING COMPUTER ASSISTED SURGICAL NAVIGATION AND THERE WERE NO COMPLICATION. ON AN UNKNOWN DATE, THE PATIENT HAD UPPER RESPIRATORY INFECTION AND CHEST X-RAY 2 VIEWS FRONTAL AND LATERAL WERE ORDERED. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - ON AN UNKNOWN DATE, RESULTS: UNKNOWN CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME- UNKNOWN FOR ALL EVENTS. SERIOUSNESS CRITERIA- INTERVENTION REQUIRED FOR LEFT TOTAL KNEE ARTHROPLASTY, DISABILITY FOR LEFT KNEE SWELLING AND COULD NOT WALK. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED ON (B)(6) 2019 FOR SYNVISC-ONE. BATCH NUMBER: UNKNOWN GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON LACK OF INFORMATION PROVIDED, NO CAPA IS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMATION PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS 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 SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW DID NOT INDICATE ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 31-JAN-2019. INVESTIGATION SUMMARY RECEIVED, AND PTC RESULTS ADDED. CLINICAL COURSE UPDATED. TEXT AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 15-MAR-2019 FROM LAWYER. EVENT OF UPPER RESPIRATORY INFECTION ADDED WITH DETAILS. CLINICAL COURSE UPDATED. TEXT AMENDED ACCORDINGLY.
SANOFI COMPANY FOLLOW UP COMMENT DATED 31-JAN-2019: FOLLOW UP INFORMATION DOES NOT CHANGE PREVIOUS CASE ASSESSMENT. THIS CASE CONCERNS A PATIENT WHO HAD TREATMENT WITH SYNVISC ONE AND HAD KNEE SWELLING AND COULD NOT WALK. BASED ON THE AVAILABLE INFORMATION, PHARMACOLOGICAL PLAUSIBILITY CAN BE ESTABLISHED BETWEEN THE EVENT AND SUSPECT PRODUCT. HOWEVER, MORE INFORMATION REGARDING PATIENT'S CONCURRENT CLINICAL PRESENTATION, RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATIONS AND OTHER RISK FACTORS IS REQUIRED FOR FURTHER CASE ASSESSMENT.
COULD NOT WALK [UNABLE TO WALK]. LEFT TOTAL KNEE ARTHROPLASTY [KNEE ARTHROPLASTY]. LEFT KNEE SWELLED [KNEE SWELLING] . NERVOUSNESS [NERVOUSNESS] . LEFT MEDIAL JOINT LINE TENDERNESS [INJECTION SITE JOINT TENDERNESS]. LEFT KNEE EFFUSION [KNEE EFFUSION]. CASE NARRATIVE: THIS CASE IS CROSS-REFERENCED TO (B)(6) (SAME PATIENT). INITIAL INFORMATION RECEIVED ON 23-JAN-2019 FROM UNITED STATES REGARDING AN UNSOLICITED VALID LEGAL SERIOUS CASE RECEIVED FROM LAWYER. THIS CASE INVOLVES A (B)(6) YEARS OLD FEMALE PATIENT WHO EXPERIENCED COULD NOT WALK, LEFT KNEE SWELLED, LEFT TOTAL KNEE ARTHROPLASTY, NERVOUSNESS, LEFT MEDIAL JOINT LINE TENDERNESS AND LEFT KNEE EFFUSION, WHILE SHE WAS TREATED WITH MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE (SYNVISC ONE). THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ARTHRITIS WITH RECEIVED STEROID AND GEL INJECTIONS, GASTROINTESTINAL HAEMORRHAGE, NEPHROLITHIASIS, PULMONARY MASS, COLONOSCOPY, POLYPECTOMY, ARTHRALGIA, INJECTION SITE JOINT DISCOMFORT, JOINT STIFFNESS, DEPRESSION, DIVERTICULUM, ANXIETY, LT KNEE SCOPE, PMM, MFC AND PATELLA CHONDROPLASTY AND LOOSE BODY REMOVED LEUKOCYTOSIS, JOINT INSTABILITY, INJURY, NEPHROLITHIASIS, MENISCUS REMOVAL AND JOINT LOCK. THE PATIENT'S PAST MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT HAD ONGOING GAIT DISTURBANCE AND NON-TOBACCO USER. CONCOMITANT MEDICATIONS INCLUDED OXYCODONE; FLUOXETINE HYDROCHLORIDE (PROZAC); ZOLPIDEM TARTRATE (AMBIEN); IBUPROFEN (IBUPROFEN); AND TRAMADOL HCL (TRAMADOL HCL), VITAMIN D3 50000, GABAPENTIN, BENTYL, NAPROXEN, FLONASE ALLERGY RELIEF. ON (B)(6) 2018, THE PATIENT STARTED USING HYLAN G-F 20, SODIUM HYALURONATE INJECTION IN LEFT KNEE VIA INTRA-ARTICULAR ROUTE, DOSAGE UNKNOWN (LOT - UNK) FOR OSTEOARTHRITIS WHICH THE PATIENT TOLERATED WITHOUT ADVERSE REACTIONS OR COMPLICATIONS. ON THE SAME DAY IN THE EVENING, THE PATIENT DEVELOPED AN EVENT OF A SERIOUS COULD NOT WALK (GAIT INABILITY), LEFT KNEE SWELLED (JOINT SWELLING) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE PATIENT PRESENTED TO THE PHYSICIAN USING CRUTCHES AND WEARING ACE BANDAGES. THE PATIENT REPORTED THAT EVENING AFTER THE INJECTION, BOTH KNEES SWELLED TO THE POINT THAT SHE COULD NOT WALK AND THE PHYSICIAN HAS TO ASPIRATE THE KNEE. ON (B)(6) 2018, THE PATIENT HAD LEFT TOTAL KNEE ARTHROPLASTY (KNEE ARTHROPLASTY) AFTER USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN EVENT OF A NON-SERIOUS NERVOUSNESS, LEFT MEDIAL JOINT LINE TENDERNESS (INJECTION SITE JOINT PAIN) AFTER STARTING USE OF HYLAN G-F 20 AND SODIUM HYALURONATE. THE SURGERY FOR LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 USING COMPUTER ASSISTED SURGICAL NAVIGATION AND THERE WERE NO COMPLICATION. RELEVANT LABORATORY TEST RESULTS INCLUDED: ASPIRATION JOINT - ON AN UNKNOWN DATE, RESULTS: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME- UNKNOWN FOR ALL EVENTS. SERIOUSNESS CRITERIA- INTERVENTION REQUIRED FOR LEFT TOTAL KNEE ARTHROPLASTY, DISABILITY FOR LEFT KNEE SWELLING AND COULD NOT WALK. A PRODUCT TECHNICAL COMPLAINT WAS INITIATED ON 31-JAN-2019 FOR SYNVISC-ONE. BATCH NUMBER: UNKNOWN GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. BASED ON LACK OF INFORMATION PROVIDED, NO CAPA IS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMATION PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS 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 SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW DID NOT INDICATE ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED ON 31-JAN-2019. INVESTIGATION SUMMARY RECEIVED AND PTC RESULTS ADDED. CLINICAL COURSE UPDATED. TEXT AMENDED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126266 | SYNVISC ONE | MOZ | MOZ | GENZYME CORPORATION(RIDGEFIELD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S | AMBIEN (ZOLPIDEM TARTRATE),UNKNOWN| AMBIEN (ZOLPIDEM TARTRATE),UNKNOWN| BENTYL (DICYCLOVERINE HYDROCHLORIDE),UNKNOWN| BENTYL (DICYCLOVERINE HYDROCHLORIDE),UNKNOWN| FLONASE [MOMETASONE FUROATE],UNKNOWN| FLONASE [MOMETASONE FUROATE],UNKNOWN| GABAPENTIN (GABAPENTIN),UNKNOWN| GABAPENTIN (GABAPENTIN),UNKNOWN| IBUPROFEN (IBUPROFEN),UNKNOWN| IBUPROFEN (IBUPROFEN),UNKNOWN| OXYCODONE (OXYCODONE),UNKNOWN| OXYCODONE (OXYCODONE),UNKNOWN| PROZAC (FLUOXETINE HYDROCHLORIDE),UNKNOWN| PROZAC (FLUOXETINE HYDROCHLORIDE),UNKNOWN| TRAMADOL HCL (TRAMADOL HCL),UNKNOWN| TRAMADOL HCL (TRAMADOL HCL),UNKNOWN| VITAMIN D3 PLUS (COLECALCIFEROL),UNKNOWN| VITAMIN D3 PLUS (COLECALCIFEROL),UNKNOWN |