SYNVISC ONE
Report
- Report Number
- 2246315-2025-00013
- Event Type
- Injury
- Date Received
- February 22, 2025
- Date of Event
- February 7, 2024
- Report Date
- March 4, 2025
- Manufacturer
- GENZYME CORPORATION(RIDGEFIELD)
- Product Code
- MOZ
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SANOFI COMPANY COMMENT DATED 17-FEB-2025: THIS CASE INVOLVES A 70 YEARS OLD FEMALE PATIENT WHO COULD NOT WALK AND USED WHEELCHAIR, WAS STRUGGLING TO STAND, KNEE WAS SO SWOLLEN/STILL SWOLLEN IN THE KNEE, HAVE TO USE CRUTCHES, DURING THE INJECTION IT WAS SO PAINFUL AND BURNING, STILL PAINFUL AND HAVE TO USE CRUTCHES, FELT FLUSHED, NAUSEOUS, SWEATY, ALMOST PASSED OUT AND SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION WITH THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC ONE]. BASED ON THE AVAILABLE INFORMATION, THE CAUSAL ROLE OF THE COMPANY SUSPECT COULD NOT BE DENIED FOR THE OCCURRENCE OF ADVERSE EVENTS. HOWEVER, THE UNDERLYING CONDITION OF OSTEOARTHRITIS AND PATIENT BEING ALLERGIC TO A NUMBER OF MEDICATIONS COULD ALSO BE THE COFOUNDING REASON. FURTHER UPDATE ON INJECTION TECHNIQUE, POST INJECTION ROUTINE, WOULD AID IN BETTER ASSESSMENT OF THE CASE. THE CASE WILL BE REASSESSED BASED ON FOLLOW-UP INFORMATION THAT WILL BE RECEIVED.
WAS STRUGGLING TO STAND [DIFFICULTY IN STANDING]; COULD NOT WALK, AND USED WHEELCHAIR [UNABLE TO WALK]; KNEE IS SO SWOLLEN/STILL SWOLLEN IN THE KNEE, HAVE TO USE CRUTCHES [INJECTION SITE JOINT SWELLING]; DURING THE INJECTION IT WAS SO PAINFUL AND BURNING, STILL PAINFUL AND HAVE TO USE CRUTCHES [INJECTION SITE JOINT PAIN]; FELT FLUSHED [FLUSHED]; NAUSEOUS [NAUSEOUS]; SWEATY [SWEATY]; ALMOST PASSED OUT [NEAR FAINTING]; SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION [ALLERGY]. CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 11-FEB-2025 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES A 70 YEARS OLD FEMALE PATIENT WHO COULD NOT WALK AND USED WHEELCHAIR, WAS STRUGGLING TO STAND, KNEE WAS SO SWOLLEN/STILL SWOLLEN IN THE KNEE, HAVE TO USE CRUTCHES, DURING THE INJECTION IT WAS SO PAINFUL AND BURNING, STILL PAINFUL AND HAVE TO USE CRUTCHES, FELT FLUSHED, NAUSEOUS, SWEATY, ALMOST PASSED OUT AND SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION WITH THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC ONE]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT WAS ALLERGIC TO A NUMBER OF MEDICATIONS, PENICILLIN AND ANY OF THE OTHER DIRECTIVES OF IT, STEROIDS, SELDANE, SULFAS, LATEX, BENADRYL, AND TETANUS SHOTS, AS WELL AS WASPS AND YELLOWJACKETS. ON (B)(6) 2024, THE PATIENT RECEIVED HYLAN G-F 20, SODIUM HYALURONATE INJECTION (STRENGTH: 48MG/6ML) IN LEFT KNEE ONCE VIA ROUTE INTRA-ARTICULAR (DOSE UNKNOWN) FOR OSTEOARTHRITIS. RIGHT AFTER THE INJECTION PATIENT FELT FLUSHED (FLUSHING), NAUSEOUS (NAUSEA), SWEATY (HYPERHIDROSIS) AND ALMOST PASSED OUT (PRESYNCOPE) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN). SHE COULD NOT WALK AND SOMEONE THAT WORKED THERE SAW HER AND HER NEIGHBOR AS SHE WAS STRUGGLING TO STAND (DYSSTASIA) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) AND GAVE HER A WHEELCHAIR (GAIT INABILITY) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN). DURING THE INJECTION SHE ASKED DOCTOR TO STOP BECAUSE IT WAS SO PAINFUL AND BURNING (INJECTION SITE JOINT PAIN) (ONSET DATE: (B)(6) 2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) BUT HE SAID HE WAS ALMOST FINISHED AN THEN PUSHED THE REST INTO THE PATIENT. THE DOCTOR AND OFFICE STATED ABOUT A WEEK AFTER THE INJECTION THAT THEY HAD NEVER SEEN THIS INJECTION CAUSE THIS MUCH SWELLING (INJECTION SITE JOINT SWELLING) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) BEFORE AND THE DOCTOR TOLD PATIENT PRIOR THAT ONLY 2% OF PEOPLE HAD ANY ISSUES BUT PATIENT RESEARCHED THIS AND IT WAS MORE LIKE 22%. SHE SAID SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION (HYPERSENSITIVITY) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) BUT SHE DID NOT KNOW. PATIENT STILL HAD ADVERSE REACTIONS FROM THE INJECTION SHE RECEIVED ON HER LEFT KNEE AND STILL WAS ON CRUTCHES SINCE GETTING THE INJECTION ONE YEAR AGO. SHE SAID SHE WAS STILL SWOLLEN IN THE KNEE (INJECTION SITE JOINT SWELLING) AND IT WAS STILL PAINFUL (INJECTION SITE JOINT PAIN) AND HAD TO USE CRUTCHES. PATIENT JUST WISHED THE DOCTOR WOULD HAVE TOLD HER ABOUT POSSIBLE SIDE EFFECTS BECAUSE IF SHE WOULD HAVE KNOWN SHE WOULD HAVE NEVER GONE THROUGH WITH GETTING THIS INJECTION. HER KNEE WAS SO SWOLLEN THAT NO OTHER DOCTOR WOULD CUT IT OPEN FOR FEAR THAT IT WOULD JUST MUSHROOM OUT. THE PATIENT JUST NEED TO BE ABLE TO WALK AGAIN. INFORMATION ON BATCH NUMBER AND EXPIRATION DATE CORRESPONDING TO THE ONE AT TIME OF EVENT OCCURRENCE WAS REQUESTED. ACTION TAKEN: NOT APPLICABLE FOR ALL EVENTS. CORRECTIVE TREATMENT: WHEELCHAIR AND USING CRUTCHES FOR GAIT INABILITY, DYSSTASIA, USING CRUTCHES FOR INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT SWELLING, NOT REPORTED FOR REST OF THE EVENTS. AT TIME OF REPORTING, THE OUTCOME WAS NOT RECOVERED FOR GAIT INABILITY, INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT SWELLING; UNKNOWN FOR REST OF THE EVENTS. SERIOUSNESS CRITERIA: DISABILITY FOR DYSSTASIA, GAIT INABILITY, INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT SWELLING.
WAS STRUGGLING TO STAND [DIFFICULTY IN STANDING] COULD NOT WALK, AND USED WHEELCHAIR [UNABLE TO WALK] KNEE IS SO SWOLLEN/STILL SWOLLEN IN THE KNEE, HAVE TO USE CRUTCHES [INJECTION SITE JOINT SWELLING] DURING THE INJECTION IT WAS SO PAINFUL AND BURNING, STILL PAINFUL AND HAVE TO USE CRUTCHES [INJECTION SITE JOINT PAIN] SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION [ALLERGY] ([FLUSHED], [NAUSEOUS], [SWEATY], [NEAR FAINTING]). CASE NARRATIVE: INITIAL INFORMATION RECEIVED ON 11-FEB-2025 REGARDING AN UNSOLICITED VALID SERIOUS CASE RECEIVED FROM A PATIENT. THIS CASE INVOLVES A 70 YEARS OLD FEMALE PATIENT WHO COULD NOT WALK AND USED WHEELCHAIR, WAS STRUGGLING TO STAND, KNEE WAS SO SWOLLEN/STILL SWOLLEN IN THE KNEE, HAVE TO USE CRUTCHES, DURING THE INJECTION IT WAS SO PAINFUL AND BURNING, STILL PAINFUL AND HAVE TO USE CRUTCHES AND SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION WITH THE USE OF MEDICAL DEVICE HYLAN G-F 20, SODIUM HYALURONATE [SYNVISC ONE]. THE PATIENT'S PAST MEDICAL HISTORY, MEDICAL TREATMENT(S), VACCINATION(S) AND FAMILY HISTORY WERE NOT PROVIDED. AT THE TIME OF THE EVENT, THE PATIENT WAS ALLERGIC TO A NUMBER OF MEDICATIONS, PENICILLIN AND ANY OF THE OTHER DIRECTIVES OF IT, STEROIDS, SELDANE, SULFAS, LATEX, BENADRYL, AND TETANUS SHOTS, AS WELL AS WASPS AND YELLOWJACKETS. ON (B)(6) 2024, THE PATIENT RECEIVED HYLAN G-F 20, SODIUM HYALURONATE INJECTION (STRENGTH: 48MG/6ML) IN LEFT KNEE ONCE VIA ROUTE INTRA-ARTICULAR (DOSE UNKNOWN) FOR OSTEOARTHRITIS. RIGHT AFTER THE INJECTION PATIENT FELT FLUSHED (FLUSHING), NAUSEOUS (NAUSEA), SWEATY (HYPERHIDROSIS) AND ALMOST PASSED OUT (PRESYNCOPE) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN). SHE COULD NOT WALK AND SOMEONE THAT WORKED THERE SAW HER AND HER NEIGHBOR AS SHE WAS STRUGGLING TO STAND (DYSSTASIA) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) AND GAVE HER A WHEELCHAIR (GAIT INABILITY) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN). DURING THE INJECTION SHE ASKED DOCTOR TO STOP BECAUSE IT WAS SO PAINFUL AND BURNING (INJECTION SITE JOINT PAIN) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) BUT HE SAID HE WAS ALMOST FINISHED AN THEN PUSHED THE REST INTO THE PATIENT. THE DOCTOR AND OFFICE STATED ABOUT A WEEK AFTER THE INJECTION THAT THEY HAD NEVER SEEN THIS INJECTION CAUSE THIS MUCH SWELLING (INJECTION SITE JOINT SWELLING) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) BEFORE AND THE DOCTOR TOLD PATIENT PRIOR THAT ONLY 2% OF PEOPLE HAD ANY ISSUES BUT PATIENT RESEARCHED THIS AND IT WAS MORE LIKE 22%. SHE SAID SHE MIGHT BE ALLERGIC TO SOMETHING IN THE MEDICATION (HYPERSENSITIVITY) (ONSET DATE: 07-FEB-2024, LATENCY: SAME DAY) (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) BUT SHE DID NOT KNOW. PATIENT STILL HAD ADVERSE REACTIONS FROM THE INJECTION SHE RECEIVED ON HER LEFT KNEE AND STILL WAS ON CRUTCHES SINCE GETTING THE INJECTION ONE YEAR AGO. SHE SAID SHE WAS STILL SWOLLEN IN THE KNEE AND IT WAS STILL PAINFUL AND HAD TO USE CRUTCHES. PATIENT JUST WISHED THE DOCTOR WOULD HAVE TOLD HER ABOUT POSSIBLE SIDE EFFECTS BECAUSE IF SHE WOULD HAVE KNOWN SHE WOULD HAVE NEVER GONE THROUGH WITH GETTING THIS INJECTION. HER KNEE WAS SO SWOLLEN THAT NO OTHER DOCTOR WOULD CUT IT OPEN FOR FEAR THAT IT WOULD JUST MUSHROOM OUT. PATIENT HAD TRIED TO TALK TO THE DOCTOR, BUT THE OFFICE WOULD NOT RETURN HER CALLS AND NO OTHER DOCTOR WOULD TOUCH HER. PATIENT JUST WANTED ANSWERS AND SOME RELIEF. SHE REPORTED SHE HAD A FARM AND COULD NOT DO IT ON CRUTCHES AS SHE BY HERSELF SINCE HER HUSBAND HAD PASSED. PATIENT ALSO STATED THAT THERE SHOULD BE AN ALLERGY PATCH TEST BEFORE USING THIS PRODUCT SO PEOPLE WOULD BETTER UNDERSTAND THE RISKS. THE PATIENT JUST NEEDED TO BE ABLE TO WALK AGAIN. UPON FOLLOW UP PATIENT REPORTED THAT THEY SENT HER A KIT AND WANTED HER TO SENT BACK THE SAMPLE IT WAS A BOX, A BIOHAZARD BAG, A CARDBOARD CONTAINER AND ANOTHER SAFE PACKING MATERIAL. IT WAS REPORTED THAT QUALITY DEPARTMENT ROUTINE PROCESS OF ATTEMPTING TO RETRIEVE A PRODUCT IF IT WAS STILL AVAILABLE, BUT SOMETIMES IT HAD ALREADY BEEN DISCARDED. IT WAS ALSO REPORTED THAT QUALITY DEPARTMENT WOULD BE INFORMED THAT THE PRODUCT WAS NO LONGER AVAILABLE. PATIENT REPORTED THAT SHE WOULD HOLD ON TO THE KIT AND WOULD NOT MIND TO GO TO THE DOCTOR TO HAVE A SAMPLE PULLED OUT OF HER KNEE. NO FURTHER INFORMATION WAS REPORTED. INFORMATION ON BATCH NUMBER AND EXPIRATION DATE CORRESPONDING TO THE ONE AT TIME OF EVENT OCCURRENCE WAS REQUESTED. ACTION TAKEN: NOT APPLICABLE FOR ALL EVENTS. CORRECTIVE TREATMENT: WHEELCHAIR AND USING CRUTCHES FOR GAIT INABILITY, DYSSTASIA, USING CRUTCHES FOR INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT SWELLING, NOT REPORTED FOR HYPERSENSITIVITY. AT TIME OF REPORTING, THE OUTCOME WAS NOT RECOVERED FOR GAIT INABILITY, INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT SWELLING; UNKNOWN FOR REST OF THE EVENTS. SERIOUSNESS CRITERIA: DISABILITY FOR DYSSTASIA, GAIT INABILITY, INJECTION SITE JOINT PAIN AND INJECTION SITE JOINT SWELLING. A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED ON (B)(6)2025 FOR SYNVISC ONE (BATCH NUMBER AND EXPIRY DATE: UNKNOWN) WITH GLOBAL PTC NUMBER: (B)(4). PTC STATED: INVESTIGATION: BASED ON THE COMPLAINT FROM INTAKE TEAM, THERE WAS NO QUALITY RELATED DEFECT THAT WOULD ATTRIBUTE TO A MALFUNCTION A DEATH OR SERIOUS INJURY. 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. THE PRODUCT LOT NUMBER WAS NOT PROVIDED. A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASED ON THE LACK OF INFORMATION, NO ASSESSMENT WAS POSSIBLE. 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 NONCONFORMING MATERIAL OR PRODUCT PROCESS. SANOFI WILL CONTINUE TO MONITOR ADVERSE EVENTS AND PERFORM TREND ANALYSIS ON A PERIODIC BASIS COMPLAINT HANDLING TO DETERMINE IF A CAPA (CORRECTIVE AND PREVENTIVE ACTION) WAS REQUIRED. THE FINAL PTC WAS COMPLETED ON (B)(6)2025 WITH SUMMARIZED CONCLUSION AS NO ASSESSMENT POSSIBLE. FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6)2025 FROM PATIENT. NO NEW SIGNIFICANT INFORMATION RECEIVED. TEXT AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2025 FROM QUALITY DEPARTMENT. PTC RESULTS WERE ADDED. UPON INTERNAL REVIEW THE EVENTS OF NAUSEA, FLUSHING, HYPERHIDROSIS AND PRESYNCOPE WERE UPDATED AS SYMPTOMS OF HYPERSENSITIVITY. TEXT AMENDED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1619929 | SYNVISC ONE | MOZ | MOZ | GENZYME CORPORATION(RIDGEFIELD) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Disability |