SYNVISC
Report
- Report Number
- 2246315-2018-00311
- Event Type
- Injury
- Date Received
- February 19, 2018
- Date of Event
- December 1, 2017
- Report Date
- February 6, 2018
- Manufacturer
- GENZYME BIOSURGERY (RIDGEFIELD)
- Product Code
- MOZ
- PMA / PMN Number
- P940015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PATIENT
Narratives
THIS SPONTANEOUS CASE FROM UNITED STATES WAS RECEIVED ON 06-FEB-2018 FROM PATIENT'S WIFE THIS CASE CONCERNS 67 YEARS OLD MALE PATIENT WHO INITIATED TREATMENT WITH SYNVISC AND FEW DAYS HAD TO DRAWN 111 CC OFF THE LEFT KNEE AND FOUR DAYS LATER THEY DREW 123 CC OF FLUID OFF THE SAME KNEE DREW SOME FLUID OF THE LEFT KNEE THIS PAST WEEK BUT IT WAS MINIMAL, "SCREAMS LIKE A GIRLY MAN" HIGH THAN 10/ SEVERE PAIN, HE HAS BASICALLY BEEN INCAPACITATED, PRIOR TO HIS THIRD SYNVISC INJECTION HIS CONDITION WAS WORSENING; AFTER UNKNOWN LATENCY HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET, COULD NOT STAND TO BEND THE LEFT KNEE OR BARE WEIGHT, COULD NOT STAND TO BEND THE LEFT KNEE OR BARE WEIGHT, MUSCLE DETERIORATION, LEFT LEG IS PRETTY LOCKED UP, TEMPERATURE OF 100 DEGREES F A WEEK AGO AND DID NOT DRIVE. NO MEDICAL HISTORY, PREVIOUS MEDICATIONS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. PATIENT HAD A HISTORY OF BLOOD CLOTTING DISORDER AND OSTEOARTHRITIS AND HE WAS TAKING CLOPIDOGREL BISULFATE (PLAVIX) AND WARFARIN SODIUM (COUMADIN) ON (B)(6) 2017, (B)(6) 2018 AND (B)(6) 2017 PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC INJECTION AT A DOSE OF 8 MG/ML WEEKLY ONCE BILATERAL KNEE FOR OSTEOARTHRITIS (BATCH/ LOT NUMBER: N10840A AND EXPIRY DATE: UNKNOWN). REPORTER SAID THAT IMMEDIATELY PRIOR TO PATIENT'S THIRD SYNVISC INJECTION HIS CONDITION WAS WORSENING AND GOT THE THIRD INJECTION HE HAS BASICALLY BEEN INCAPACITATED; AFTER THE SECOND INJECTION THEY HAD TO DRAWN 111 CC OFF THE LEFT KNEE AND FOUR DAYS LATER THEY DREW 123 CC OF FLUID OFF THE SAME KNEE. THEY CULTURE BOTH TIMES THAT FLUID FROM THE LEFT KNEE AND IT CAME BACK NEGATIVE. THEY SAID THEY DREW SOME FLUID OF THE LEFT KNEE THIS PAST WEEK BUT IT WAS MINIMAL. PATIENT SCREAMED LIKE A GIRLY MAN, ON A SCALE ON 1 TO 10 THE PAIN LEVEL WAS HIGH THAN 10. HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS. SHE SAID SHE HAD TO BUY A LIFT CHAIR FOR HIM BECAUSE SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET. SHE SAID HE COULD NOT STAND TO BEND THE LEFT KNEE OR BARE WEIGHT. HE NOW HAD SOME MUSCLE DETERIORATION AND THE LEFT LEG IS PRETTY LOCKED UP. THEY DID MRI ON HIS LEFT KNEE A COUPLE OF WEEKS AGO TO SEE WHAT WAS CAUSING THE SEVERE PAIN. HE HAD MILD MENISCUS FRAYING AND CHONDROMALACIA BEHIND THE KNEE AND BOTH WERE VERY MINOR. SHE SAID HE DID HAVE A TEMPERATURE OF 100 DEGREES F A WEEK AGO IN THE PHYSICIAN'S OFFICE BUT HE NORMALLY HAD A LAW TEMPERATURE AROUND THE 96 DEGREES F. CORRECTIVE TREATMENT: LIFT CHAIR FOR HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDEOF THE BED, AND EVEN OFF THE TOILET; NOT REPORTED FOR OTHERS OUTCOME: RECOVERING FOR TEMPERATURE OF 100 DEGREES F A WEEK AGO; NOT RECOVERED FOR OTHERS SERIOUSNESS CRITERIA: DISABILITY FOR HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED WITH GLOBAL PTC NUMBER: 52456 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 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 SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THIS REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. SANOFI WOULD CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 28-FEB-2018. PTC (PHARMACEUTICAL TECHNICAL COMPLAINT) RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 28-FEB-2018: FOLLOW UP INFORMATION RECEIVED, DOES NOT CHANGE PREVIOUS CASE ASSESSMENT. THIS CASE CONCERNS A PATIENT WHO HAS RECEIVED SYNVISC IINJECTION FROM THE AND LATER EXPERIENCED DECREASED MOBILITY AND OTHER ADVERSE EVENTS. A TEMPORAL RELATIONSHIP CAN BE ESTABLISHED WITH THE PRODUCT ADMINISTRATION. HOWEVER, LACK OF INFORMATION REGARDING PATIENT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS MAKES THE COMPLETE CASE ASSESSMENT DIFFICULT.
THIS SPONTANEOUS CASE FROM UNITED STATES WAS RECEIVED ON 06-FEB-2018 FROM PATIENT'S WIFE THIS CASE CONCERNS (B)(6) MALE PATIENT WHO INITIATED TREATMENT WITH SYNVISC AND FEW DAYS HAD TO DRAWN 111 CC OFF THE LEFT KNEE AND FOUR DAYS LATER THEY DREW 123 CC OF FLUID OFF THE SAME KNEE DREW SOME FLUID OF THE LEFT KNEE THIS PAST WEEK BUT IT WAS MINIMAL, "SCREAMS LIKE A GIRLY MAN" HIGH THAN 10/ SEVERE PAIN, HE HAS BASICALLY BEEN INCAPACITATED, PRIOR TO HIS THIRD SYNVISC INJECTION HIS CONDITION WAS WORSENING; AFTER UNKNOWN LATENCY HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET, COULD NOT STAND TO BEND THE LEFT KNEE OR BARE WEIGHT, COULD NOT STAND TO BEND THE LEFT KNEE OR BARE WEIGHT, MUSCLE DETERIORATION, LEFT LEG IS PRETTY LOCKED UP, TEMPERATURE OF 100 DEGREES F A WEEK AGO AND DID NOT DRIVE NO MEDICAL HISTORY, PREVIOUS MEDICATIONS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. PATIENT HAD A HISTORY OF BLOOD CLOTTING DISORDER AND OSTEOARTHRITIS AND HE WAS TAKING CLOPIDOGREL BISULFATE (PLAVIX) AND WARFARIN SODIUM (COUMADIN) ON (B)(6) 2017, (B)(6) 2018 AND (B)(6) 2017 PATIENT RECEIVED TREATMENT WITH INTRA ARTICULAR SYNVISC INJECTION AT A DOSE OF 8 MG/ML WEEKLY ONCE BILATERAL KNEE FOR OSTEOARTHRITIS (BATCH/ LOT NUMBER: N10840A AND EXPIRY DATE: UNKNOWN). REPORTER SAID THAT IMMEDIATELY PRIOR TO PATIENT'S THIRD SYNVISC INJECTION HIS CONDITION WAS WORSENING AND GOT THE THIRD INJECTION HE HAS BASICALLY BEEN INCAPACITATED; AFTER THE SECOND INJECTION THEY HAD TO DRAWN 111 CC OFF THE LEFT KNEE AND FOUR DAYS LATER THEY DREW 123 CC OF FLUID OFF THE SAME KNEE. THEY CULTURE BOTH TIMES THAT FLUID FROM THE LEFT KNEE AND IT CAME BACK NEGATIVE. THEY SAID THEY DREW SOME FLUID OF THE LEFT KNEE THIS PAST WEEK BUT IT WAS MINIMAL. PATIENT SCREAMED LIKE A GIRLY MAN, ON A SCALE ON 1 TO 10 THE PAIN LEVEL WAS HIGH THAN 10. HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS. SHE SAID SHE HAD TO BUY A LIFT CHAIR FOR HIM BECAUSE SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET. SHE SAID HE COULD NOT STAND TO BEND THE LEFT KNEE OR BARE WEIGHT. HE NOW HAD SOME MUSCLE DETERIORATION AND THE LEFT LEG IS PRETTY LOCKED UP. THEY DID MRI ON HIS LEFT KNEE A COUPLE OF WEEKS AGO TO SEE WHAT WAS CAUSING THE SEVERE PAIN. HE HAD MILD MENISCUS FRAYING AND CHONDROMALACIA BEHIND THE KNEE AND BOTH WERE VERY MINOR. SHE SAID HE DID HAVE A TEMPERATURE OF 100 DEGREES F A WEEK AGO IN THE PHYSICIAN'S OFFICE BUT HE NORMALLY HAD A LAW TEMPERATURE AROUND THE 96 DEGREES F. CORRECTIVE TREATMENT: LIFT CHAIR FOR HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET; NOT REPORTED FOR OTHERS. OUTCOME: RECOVERING FOR TEMPERATURE OF 100 DEGREES F A WEEK AGO; NOT RECOVERED FOR OTHERS SERIOUSNESS CRITERIA: DISABILITY FOR HE DID NOT DRIVE OR GET OUT OF THE BED OR THE RECLINER FOR THE LAST 6 OR 7 WEEKS SHE HAD TO LIFT HIM, UP AND DOWN OUT OF THE CHAIR AND OFF THE SIDE OF THE BED, AND EVEN OFF THE TOILET A PRODUCT TECHNICAL COMPLAINT WAS INITIATED AND THE RESULTS FOR THE SAME WERE PENDING. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 12-FEB-2018: THIS CASE CONCERNS A PATIENT WHO HAS RECEIVED SYNVISC INJECTION FROM THE AND LATER EXPERIENCED DECREASED MOBILITY AND OTHER ADVERSE EVENTS. A TEMPORAL RELATIONSHIP CAN BE ESTABLISHED WITH THE PRODUCT ADMINISTRATION. HOWEVER, LACK OF INFORMATION REGARDING PATIENT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS MAKES THE COMPLETE CASE ASSESSMENT DIFFICULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123575 | SYNVISC | INTRA-ARTICULAR HYALURONIC ACID | MOZ | GENZYME BIOSURGERY (RIDGEFIELD) | N10840A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Disability | COUMADIN(CON.)| COUMADIN(CON.)| PLAVIX(CON.)| PLAVIX(CON.) |