SYNVISC
Report
- Report Number
- 2246315-2022-00070
- Event Type
- Injury
- Date Received
- June 27, 2022
- Date of Event
- January 1, 2022
- Report Date
- September 2, 2022
- Manufacturer
- GENZYME CORPORATION(RIDGEFIELD)
- Product Code
- MOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
REMOVED 160CC'S OF YELLOW FLUID [ARTHROCENTESIS], LEFT KNEE WAS FILLED WITH FLUID [KNEE EFFUSION], COULD NOT BEND HIS KNEE [JOINT RANGE OF MOTION DECREASED], HARD TO STAND UP [DIFFICULTY IN STANDING], DID AN ULTRASOUND AND SAW POCKETS OF THINGS [ULTRASOUND SCAN ABNORMAL], PAIN WAS SO BAD [KNEE PAIN]. CASE NARRATIVE: INITIAL INFORMATION WAS RECEIVED FROM UNITED STATES ON 21-JUN-2022 REGARDING AN UNSOLICITED VALID SERIOUS CASE FROM A PATIENT. THIS CASE INVOLVES A 65 YEARS OLD MALE PATIENT WHO GOT REMOVED 160CC'S OF YELLOW FLUID, LEFT KNEE WAS FILLED WITH FLUID, COULD NOT BEND HIS KNEE, HARD TO STAND UP, DID AN ULTRASOUND AND SAW POCKETS OF THINGS AND PAIN WAS SO BAD AFTER TREATED WITH MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED CORTISONE. HE WAS GETTING CORTISONE SHOTS AND IT LASTED 30 DAYS. IN 2022, THE PATIENT RECEIVED THIRD SHOT OF SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE) INJECTION SERIES (DOSE, FREQUENCY, ROUTE, INDICATION, LOT, EXPIRY DATE - UNKNOWN). INFORMATION ON BATCH NUMBER WAS REQUESTED. ON AN UNKNOWN DATE IN (B)(6) 2022, HE WAS APPROVED FOR SYNVISC THROUGH (B)(6) (HEALTHCARE COMPANY) 5 WEEKS AGO. ON AN UNKNOWN DATE IN 2022 ((B)(6)), AFTER UNKNOWN LATENCY, AFTER HIS THIRD SHOT THE PAIN WAS SO BAD (ARTHRALGIA) AND HIS LEFT KNEE WAS FILLED WITH FLUID (JOINT EFFUSION, MEDICALLY SIGNIFICANT). HE WENT BACK ON (B)(6) 2022. HE COULD NOT BEND HIS KNEE (JOINT RANGE OF MOTION DECREASED) AND IT WAS HARD TO STAND UP (DYSSTASIA). HIS DOCTOR DID AN ULTRASOUND AND SAW POCKETS OF THINGS (ULTRASOUND SCAN ABNORMAL) BUT IT WAS NOT AS BAD AS IT WAS BEFORE. HIS DOCTOR REMOVED 160CC'S OF YELLOW FLUID (ASPIRATION JOINT, MEDICALLY SIGNIFICANT). HIS DOCTOR WANT TO DO AN MRI (MAGNETIC RESONANCE IMAGING). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER. THE PATIENT ASKED IF THERE WAS ANYTHING THAT HE COULD DO TO COMBAT IT AND FEEL BETTER. ACTION TAKEN: NOT APPLICABLE FOR ALL THE EVENTS. CORRECTIVE TREATMENT: REMOVED 160CC'S OF YELLOW FLUID FOR JOINT EFFUSION, NOT REPORTED FOR REST ALL EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS RECOVERING FOR THE EVENT DID AN ULTRASOUND AND SAW POCKETS OF THINGS; UNKNOWN FOR REST ALL EVENTS. A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED, AND THE RESULTS WERE PENDING FOR THE SAME.
REMOVED 160CC'S OF YELLOW FLUID [ARTHROCENTESIS]. LEFT KNEE WAS FILLED WITH FLUID [KNEE EFFUSION]. COULD NOT BEND HIS KNEE [JOINT RANGE OF MOTION DECREASED]. HARD TO STAND UP [DIFFICULTY IN STANDING]. DID AN ULTRASOUND AND SAW POCKETS OF THINGS [ULTRASOUND SCAN ABNORMAL]. PAIN WAS SO BAD/PAIN IN HIS INNER KNEE [KNEE PAIN]. CASE NARRATIVE: INITIAL INFORMATION WAS RECEIVED FROM UNITED STATES ON 21-JUN-2022 REGARDING AN UNSOLICITED VALID SERIOUS CASE FROM A PATIENT. THIS CASE INVOLVES A 65 YEARS OLD MALE PATIENT WHO GOT REMOVED 160CC'S OF YELLOW FLUID, LEFT KNEE WAS FILLED WITH FLUID, COULD NOT BEND HIS KNEE, HARD TO STAND UP, DID AN ULTRASOUND AND SAW POCKETS OF THINGS AND PAIN WAS SO BAD/PAIN IN HIS INNER KNEE AFTER TREATED WITH MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED CORTISONE. HE WAS GETTING CORTISONE SHOTS AND IT LASTED 30 DAYS. ON AN UNKNOWN DATE IN MAY-2022 (5 WEEKS AGO), THE PATIENT RECEIVED SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE, 16 MG/2ML) INJECTION, LIQUID SOLUTION, (DOSE, FREQUENCY, ROUTE, INDICATION, LOT, EXPIRY DATE - UNKNOWN). INFORMATION ON BATCH NUMBER WAS REQUESTED. ON AN UNKNOWN DATE IN MAY-2022, HE WAS APPROVED FOR SYNVISC THROUGH AETNA (HEALTHCARE COMPANY) 5 WEEKS AGO. ON AN UNKNOWN DATE IN 2022 (MAY OR JUN), AFTER UNKNOWN LATENCY, AFTER HIS FIRST SHOT HE HAD PAIN IN HIS INNER KNEE (ARTHRALGIA). AFTER HIS THIRD SHOT THE PAIN WAS SO BAD (ARTHRALGIA) AND HIS LEFT KNEE WAS FILLED WITH FLUID (JOINT EFFUSION, MEDICALLY SIGNIFICANT, INTERVENTION REQUIRED). HE WENT BACK ON (B)(6) 2022. HE COULD NOT BEND HIS KNEE (JOINT RANGE OF MOTION DECREASED) AND IT WAS HARD TO STAND UP (DYSSTASIA). HIS DOCTOR DID AN ULTRASOUND AND SAW POCKETS OF THINGS (ULTRASOUND SCAN ABNORMAL) BUT IT WAS NOT AS BAD AS IT WAS BEFORE. HIS DOCTOR REMOVED 160CC'S OF YELLOW FLUID (ASPIRATION JOINT, MEDICALLY SIGNIFICANT, INTERVENTION REQUIRED). HIS DOCTOR WANT TO DO AN MRI (MAGNETIC RESONANCE IMAGING). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER. THE PATIENT ASKED IF THERE WAS ANYTHING THAT HE COULD DO TO COMBAT IT AND FEEL BETTER. REPORTEDLY, THE SYRINGES WERE DISCARDED. ACTION TAKEN: NO ACTION TAKEN FOR ARTHRALGIA, NOT APPLICABLE FOR REST ALL THE EVENTS. CORRECTIVE TREATMENT: REMOVED 160CC'S OF YELLOW FLUID FOR JOINT EFFUSION, NOT REPORTED FOR REST ALL EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS RECOVERING FOR THE EVENT DID AN ULTRASOUND AND SAW POCKETS OF THINGS; UNKNOWN FOR REST ALL EVENTS. PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER (B)(6) ON 21-JUN-2022 FOR SYNVISC, BATCH NUMBER: UNKNOWN AND RESULTS WERE PENDING FOR THE SAME. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JUN-2022 FROM OTHER HEALTHCARE PROFESSIONAL (FROM QUALITY DEPARTMENT). GPTC (GLOBAL PRODUCT TECHNICAL COMPLAINT) NUMBER WAS ADDED. UPON INTERNAL REVIEW, AS REPORTED TERM FOR ARTHRALGIA WAS UPDATED. TEXT AMENDED ACCORDINGLY.
REMOVED 160CC'S OF YELLOW FLUID [ARTHROCENTESIS] LEFT KNEE WAS FILLED WITH FLUID [KNEE EFFUSION] COULD NOT BEND HIS KNEE [JOINT RANGE OF MOTION DECREASED] HARD TO STAND UP [DIFFICULTY IN STANDING] DID AN ULTRASOUND AND SAW POCKETS OF THINGS [ULTRASOUND SCAN ABNORMAL] PAIN WAS SO BAD/PAIN IN HIS INNER KNEE [KNEE PAIN]. CASE NARRATIVE: INITIAL INFORMATION WAS RECEIVED FROM UNITED STATES ON 21-JUN-2022 REGARDING AN UNSOLICITED VALID SERIOUS CASE FROM A PATIENT. THIS CASE INVOLVES A 65 YEARS OLD MALE PATIENT WHO GOT REMOVED 160CC'S OF YELLOW FLUID, LEFT KNEE WAS FILLED WITH FLUID, COULD NOT BEND HIS KNEE, HARD TO STAND UP, DID AN ULTRASOUND AND SAW POCKETS OF THINGS AND PAIN WAS SO BAD/PAIN IN HIS INNER KNEE AFTER TREATED WITH MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. CONCOMITANT MEDICATIONS INCLUDED CORTISONE. HE WAS GETTING CORTISONE SHOTS AND IT LASTED 30 DAYS. ON AN UNKNOWN DATE IN (B)(6) 2022 (5 WEEKS AGO), THE PATIENT RECEIVED SYNVISC (HYLAN G-F 20, SODIUM HYALURONATE, 16 MG/2ML) INJECTION, LIQUID SOLUTION, (DOSE, FREQUENCY, ROUTE, INDICATION, LOT, EXPIRY DATE - UNKNOWN). INFORMATION ON BATCH NUMBER WAS REQUESTED. ON AN UNKNOWN DATE IN (B)(6) 2022, HE WAS APPROVED FOR SYNVISC THROUGH (B)(6) (HEALTHCARE COMPANY) 5 WEEKS AGO. ON AN UNKNOWN DATE IN 2022 (B)(6), AFTER UNKNOWN LATENCY, AFTER HIS FIRST SHOT HE HAD PAIN IN HIS INNER KNEE (ARTHRALGIA). AFTER HIS THIRD SHOT THE PAIN WAS SO BAD (ARTHRALGIA) AND HIS LEFT KNEE WAS FILLED WITH FLUID (JOINT EFFUSION, MEDICALLY SIGNIFICANT, INTERVENTION REQUIRED). HE WENT BACK ON (B)(6) 2022. HE COULD NOT BEND HIS KNEE (JOINT RANGE OF MOTION DECREASED) AND IT WAS HARD TO STAND UP (DYSSTASIA). HIS DOCTOR DID AN ULTRASOUND AND SAW POCKETS OF THINGS (ULTRASOUND SCAN ABNORMAL) BUT IT WAS NOT AS BAD AS IT WAS BEFORE. HIS DOCTOR REMOVED 160CC'S OF YELLOW FLUID (ASPIRATION JOINT, MEDICALLY SIGNIFICANT, INTERVENTION REQUIRED). HIS DOCTOR WANT TO DO AN MRI (MAGNETIC RESONANCE IMAGING). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER. THE PATIENT ASKED IF THERE WAS ANYTHING THAT HE COULD DO TO COMBAT IT AND FEEL BETTER. REPORTEDLY, THE SYRINGES WERE DISCARDED. ACTION TAKEN: NO ACTION TAKEN FOR ARTHRALGIA, NOT APPLICABLE FOR REST ALL THE EVENTS. CORRECTIVE TREATMENT: REMOVED 160CC'S OF YELLOW FLUID FOR JOINT EFFUSION, NOT REPORTED FOR REST ALL EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS RECOVERING FOR THE EVENT DID AN ULTRASOUND AND SAW POCKETS OF THINGS; UNKNOWN FOR REST ALL EVENTS. A PTC (PRODUCT TECHNICAL COMPLAINT) WAS INITIATED ON 21-JUN-2022 FOR SYNVISC (WITH BATCH NUMBER: UNKNOWN) WITH GLOBAL PTC NUMBER: (B)(4). SAMPLE STATUS: NOT AVAILABLE AND PTC STATED THE PRODUCT LOT NUMBER WAS NOT PROVIDED; A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATION THROUGH NCR PROCESS. SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY CONTINUOUSLY MONITORED ADVERSE EVENT REPORTS WITH OR WITHOUT LOT NUMBERS, AND ASSESS POSSIBLE ASSOCIATIONS WITH THEIR CORRESPONDING PRODUCT LOT, AS PART OF ROUTINE SAFETY SURVEILLANCE EFFORT TO DETECT SAFETY SIGNALS. THE REVIEW HAD NOT INDICATED ANY SAFETY ISSUE. SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS AS STATED IN (B)(4) "PRODUCT EVENT HANDLING" TO DETERMINE IF A CAPA IS REQUIRED. THE FINAL INVESTIGATION WAS COMPLETED: 30-AUG-2022 WITH SUMMARIZED CONCLUSION NO ASSESSMENT POSSIBLE. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JUN-2022 FROM OTHER HEALTHCARE PROFESSIONAL (FROM QUALITY DEPARTMENT). GPTC (GLOBAL PRODUCT TECHNICAL COMPLAINT) NUMBER WAS ADDED. UPON INTERNAL REVIEW, AS REPORTED TERM FOR ARTHRALGIA WAS UPDATED. TEXT AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 30-AUG-2022 FROM QUALITY DEPARTMENT. GLOBAL PTC NUMBER AND PTC RESULTS ADDED. TEXT AMENDED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735978 | SYNVISC | MOZ | MOZ | GENZYME CORPORATION(RIDGEFIELD) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention| O | CORTISONE (CORTISONE),UNKNOWN| CORTISONE (CORTISONE),UNKNOWN| CORTISONE (CORTISONE),UNKNOWN |