SYNVISC (SYNVISC)
Report
- Report Number
- 2246315-2015-67475
- Event Type
- Injury
- Date Received
- May 27, 2015
- Date of Event
- April 23, 2015
- Report Date
- May 18, 2015
- Manufacturer
- GENZYME BIOSURGERY (RUDGEFIELD)
- Product Code
- MOZ
- PMA / PMN Number
- P940015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
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. 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. GENZYME BIOSURGERY WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 20, 2015. THE GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED.
PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED JULY 23, 2015: THIS CASE CONCERNS A (B)(6) FEMALE PATIENT WHO DEVELOPED SEVERE RIGHT AND LEFT GONARTHROSIS AFTER ADMINISTRATION OF SYNVISC INJECTION FOR GONARTHROSIS. THE EVENTS ARE TEMPORALLY RELATED TO SYNVISC AND THUS CAUSALITY OF PRODUCT CANNOT BE RULED OUT COMPLETELY, HOWEVER, CONSIDERING THE PATIENT'S AGE AND MEDICAL HISTORY OF GONARTHROSIS OF BOTH KNEES, IT IS LIKELY THAT THE EVENTS WERE RELATED TO PROGRESSIVE UNDERLYING DISEASE AND NOT TO PRODUCT AND MAY HAVE PLAYED A CONTRIBUTORY ROLE IN CAUSATION OF EVENTS. RIGHT GONARTHROSIS (GONARTHROSIS). REPORTING ORTHOPEDIST'S SERIOUSNESS ASSESSMENT: SERIOUS (MEDICALLY SIGNIFICANT AND REQUIRED INTERVENTION). REPORTING ORTHOPEDIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE. COMPANY CAUSALITY: POSSIBLE. DIAGNOSIS: LEFT GONARTHROSIS (GONARTHROSIS). REPORTING ORTHOPEDIST'S SERIOUSNESS ASSESSMENT: SERIOUS (MEDICALLY SIGNIFICANT AND REQUIRED INTERVENTION). REPORTING ORTHOPEDIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE. COMPANY CAUSALITY: POSSIBLE. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 21, 2015. THE EVENT OF FLUID RETENTION WAS REPLACED WITH GONARTHROSIS (RIGHT AND LEFT). AN ADDITIONAL EVENT OF "WAS NOT ABLE TO WALK ON HER OWN" WAS ADDED. THE EVENT TERM OF "KNEE GOT HOT" WAS UPDATED TO "BOTH KNEES GOT HOT". MEDICAL HISTORY WAS ADDED. LABORATORY TESTS WERE ADDED. CONCOMITANT DRUG (KETOPROFEN) WAS ADDED AND DEXAMETHASONE WAS CHANGED TO CORRECTIVE TREATMENT. CORRECTIVE TREATMENT (LOXOPROFEN SODIUM AND CELECOXIB) WERE ADDED. REPORTER'S COMMENT WAS ADDED. SERIOUSNESS CRITERIA (REQUIRED INTERVENTION) WAS ADDED FOR GONARTHROSIS (RIGHT AND LEFT). CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY.
IT WAS REPORTED THAT PATIENT HAD NO JOINT FLUID RETENTION, SKIN DISEASE AROUND THE JOINT, INTRA-ARTICULAR INFECTION, OR INTRA-ARTICULAR INFLAMMATION SYMPTOM OF THE KNEES PRIOR TO THE INJECTION. DISPO NEEDLE WAS USED WHILE STERILIZED GLOVE WAS NOT USED. ALCOHOL DISINFECTANT WAS USED. NO LEAKAGE OF SYNVISC SOLUTION FORM THE JOINT WAS NOTED. ON THE SAME DAY, PATIENT DEVELOPED SEVERE RIGHT AND LEFT GONARTHROSIS AND BOTH KNEES GOT HOT SINCE THAT NIGHT. ON (B)(6) 2015, BILATERAL KNEE PAIN DEVELOPED AND PATIENT HAD PYREXIA OF 38.5 0 C. ON (B)(6) 2015, THE PATIENT CALLED AN AMBULANCE FOR SEVERE PAIN AND WAS TRANSFERRED TO THE EMERGENCY ROOM OF THE REPORTING HOSPITAL AND FLUID RETENTION WAS NOTED. THE SAME DAY, ARTHROCENTESIS WAS PERFORMED AND FLUID WAS ASPIRATED FROM RIGHT KNEE (60 CC) AND LEFT KNEE (50 CC). IT WAS REPORTED THAT THE TREATMENT WITH SYNVISC WAS DISCONTINUED DUE TO THE EVENT. IT WAS REPORTED THAT LIDOCAINE HYDROCHLORIDE (XYLOCAINE) AT 20 ML WAS INJECTED ONCE ON THE DAY AS LOCAL ANAESTHETIC. THE PATIENT WAS INSTRUCTED TO REST FOR THE EVENTS. ON (B)(6) 2015, ARTHROCENTESIS WAS AGAIN PERFORMED AND FLUID WAS ASPIRATED FROM THE RIGHT KNEE (45 CC) AND LEFT KNEE (20 CC). THE SAME DAY, PATIENT'S CREATININE LEVEL WAS 0.82 MG/DL (NORMAL RANGE: 0.5-0.8MG/DL). THE PATIENT RECEIVED INJECTION OF DEXAMETHASONE (DECADRON) AT 1.5 ML ONCE INTO BOTH KNEES FOR ARTHRITIS DURING THE PROCEDURE AND LOXOPROFEN SODIUM (LOXONIN) WAS PRESCRIBED. IT WAS REPORTED THAT THE PATIENT'S WHITE BLOOD CELL COUNT (WBC) WAS 8100/MM3, AND THE PATIENT WAS CONSIDERED TO HAVE NO INFECTION. PATIENT'S INTRA-ARTICULAR INFLAMMATION SYMPTOMS WERE CONSIDERED SEVERE WITH C-REACTIVE PROTEIN (CRP) OF 0.88 MG/DL (NORMAL RANGE: 0-0.3 MG/DL), ARTHRALGIA AND JOINT FLUID RETENTION. THE SAME DAY, PATIENT'S JOINT FLUID CULTURE AND JOINT FLUID CRYSTAL EXAM WAS NEGATIVE IN BOTH KNEES AND JOINT FLUID BACTERIAL TEST WAS POSITIVE WITH WBC OF 57 (NORMAL RANGE: 30-98) AND NEUTROPHIL OF 10 (BOTH KNEES).
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A PHYSICIAN. THIS CASE CONCERNS A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD FLUID RETENTION, EXPERIENCED PYREXIA OF 38.5 DEGREE CELSIUS, SEVERE PAIN, KNEE GOT HOT AND PAIN WHILE RECEIVING TREATMENT WITH SYNVISC. NO PAST DRUG, MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITION WAS REPORTED. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (DOSE, FREQUENCY, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) FOR GONARTHROSIS INTO UNSPECIFIED KNEE AT A MEDICAL CENTER. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXERCISE REHABILITATION AFTER THE INJECTION. ON AN UNKNOWN THE PATIENT EXPERIENCED PAIN AND THE PATIENT CHANGED THE HOSPITAL TO THE REPORTING HOSPITAL. ON (B)(6) 2015, THE PATIENT RECEIVED SYNVISC INJECTION AT A DOSE OF 2 ML INTO BOTH THE KNEES ONCE. SINCE THAT NIGHT, THE PATIENT'S KNEES GOT HOT. ON (B)(6) 2015, THE PATIENT HAD PYREXIA OF 38.5 DEGREES CELSIUS. ON (B)(6) 2015, THE PATIENT CALLED AN AMBULANCE FOR SEVERE PAIN AND WAS TRANSFERRED TO THE EMERGENCY ROOM OF THE REPORTING HOSPITAL AND FLUID RETENTION WAS NOTED. THE SAME DAY, ARTHROCENTESIS WAS PERFORMED AND FLUID WAS ASPIRATED FROM RIGHT KNEE (60 CC) AND LEFT KNEE (50 CC). IT WAS REPORTED THAT THE TREATMENT WITH SYNVISC WAS DISCONTINUED DUE TO THE EVENT. IT WAS REPORTED THAT LIDOCAINE HYDROCHLORIDE (XYLOCAINE) AT 20 ML WAS INJECTED ONCE ON THE DAY AS LOCAL ANAESTHETIC. ON (B)(6) 2015, ARTHROCENTESIS WAS AGAIN PERFORMED AND FLUID WAS ASPIRATED FROM THE RIGHT KNEE (45 CC) AND LEFT KNEE (20 CC). THE PATIENT RECEIVED INJECTION OF DEXAMETHASONE (DECADRON) AT 1.5 ML ONCE INTO BOTH KNEES FOR ARTHRITIS DURING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT'S WHITE BLOOD CELL COUNT (WBC) WAS 8100/MM3, AND THE PATIENT WAS CONSIDERED TO HAVE NO INFECTION. AS OF (B)(6) 2015, THE PATIENT WAS RECOVERING FROM THE EVENT. ON (B)(6) 2015, THE PATIENT VISITED THE REPORTING HOSPITAL AND NO FLUID RETENTION WAS OBSERVED. IT WAS REPORTED THAT THE PATIENT BECAME ABLE TO WALK. ON (B)(6) 2015, THE PATIENT VISITED THE REPORTING HOSPITAL AND HAD SOME PAIN BUT WAS ALMOST RECOVERING FROM THE CONDITION. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO WALK AS USUAL. CORRECTIVE TREATMENT: NOT REPORTED FOR PYREXIA OF 38.5 DEGREES CELSIUS, SEVERE PAIN, PAIN, KNEE GOT HOT; ARTHROCENTESIS FOR FLUID RETENTION. OUTCOME: UNKNOWN FOR PYREXIA OF 38.5 DEGREES CELSIUS, SEVERE PAIN, PAIN, KNEE GOT HOT AND RECOVERING FOR FLUID RETENTION. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING. FLUID RETENTION (JOINT EFFUSION). REPORTING ORTHOPEDIST'S SERIOUSNESS ASSESSMENT: SERIOUS (MEDICALLY SIGNIFICANT). REPORTING ORTHOPEDIST'S CAUSALITY ASSESSMENT: HIGHLY PROBABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343976 | SYNVISC (SYNVISC) | INTRA-ARTICULAR HYALURONIC ACID | MOZ | GENZYME BIOSURGERY (RUDGEFIELD) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other| R | PREV MEDS = UNKNOWN| DECADRON (CON.) |