MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Lot Number ARSP007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Arthralgia (2355); Ambulation Difficulties (2544); Angioedema (4536); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6) comment dated (b)(6) 2022: this case involves a 54 years old female patient whose unable to bear weight, was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted, developed increased pain and swelling on sunday after the injection, developed increased pain and swelling on sunday after the injection and at the time of the phone call, the patient was having her right knee drained in the operating room while being treated with hylan g-f 20, sodium hyaluronate [synvisc].However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted/at the time of the phone call, the patient was having her right knee drained in the operating room [arthrocentesis].Unable to bear weight [weight bearing difficulty].Developed increased pain and swelling on sunday after the injection [injection site joint swelling].Developed increased pain and swelling on sunday after the injection [injection site joint pain].Case narrative: initial information received on 03-aug-2022 from united states regarding an unsolicited valid serious case received from the patient.This case involves a 54 years old female patient whose unable to bear weight, was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted/at the time of the phone call, the patient was having her right knee drained in the operating room , developed increased pain and swelling on sunday after the injection,while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection in her right knee at a dose of 2 ml once (lot - arsp007, expiry date: 31-mar-2023) (strength, route: unknown) for osteoarthritis.Patient had a reaction to synvisc that took the patient to the er.The patient just followed up with the orthopedic surgeon and that the patient was going to the operating room to have the knee drained.Caller stated they don't know if something was wrong with the synvisc but that the patient's next few injections have been cancelled.Caller was requesting reimbursement.Is there something wrong with the batch? what was the return and reimbursement process? caller requests reimbursement for a kit of synvisc--they will not be using 2 syringes since there was a severe reaction after the first syringe.The office had the other two syringes from the kit.This was the first time their office has ever given synvisc to this patient.On (b)(6) 2022 after a latency of 3 days patient presents for an urgent visit was in the emergency room yesterday with failed aspiration attempted/at the time of the phone call, the patient was having her right knee drained in the operating room (aspiration joint), developed increased pain and swelling on sunday after the injection (injection site joint pain) (injection site joint swelling), unable to bear weight (weight bearing difficulty).Denies fever and chills.Given a single dose of im antibiotic and then prescribed oral antibiotics, had not felt any better, is still having pain in knee when trying to move it.Action taken: drug withdrawn for all the events.Corrective treatment: a single dose of im antibiotic and then prescribed oral antibiotics for all the events.At time of reporting, the outcome was not recovered / not resolved for the event developed increased pain and swelling on sunday after the injection, , was not recovered / not resolved for the event unable to bear weight, was unknown for the event was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted/at the time of the phone call, the patient was having her right knee drained in the operating room.Seriousness criteria: hospitalization for aspiration joint.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted [arthrocentesis] unable to bear weight [weight bearing difficulty] developed increased pain and swelling on sunday after the injection [injection site joint swelling] developed increased pain and swelling on sunday after the injection [injection site joint pain] ([pain upon movement]) at the time of the phone call, the patient was having her right knee drained in the operating room [effusion (r) knee] case narrative: initial information received on 03-aug-2022 from united states regarding an unsolicited valid serious case received from the patient.This case involves a 54 years old female patient whose unable to bear weight, was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted, developed increased pain and swelling on sunday after the injection, developed increased pain and swelling on sunday after the injection and at the time of the phone call, the patient was having her right knee drained in the operating room while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection in her right knee at a dose of 2 ml once (lot - arsp007, expiry date: 31-mar-2023) having the strength 16mg/2ml (route: unknown) for osteoarthritis.Patient had a reaction to synvisc that took the patient to the er.The patient just followed up with the orthopedic surgeon and that the patient was going to the operating room to have the knee drained.Caller stated they don't know if something was wrong with the synvisc but that the patient's next few injections have been cancelled.Caller was requesting reimbursement.Is there something wrong with the batch? what was the return and reimbursement process? caller requests reimbursement for a kit of synvisc--they will not be using 2 syringes since there was a severe reaction after the first syringe.The office had the other two syringes from the kit.This was the first time their office has ever given synvisc to this patient.On (b)(6) 2022 after a latency of 3 days patient presents for an urgent visit was in the emergency room yesterday with failed aspiration attempted (aspiration joint), developed increased pain and swelling on sunday after the injection (injection site joint pain) (injection site joint swelling), unable to bear weight (weight bearing difficulty).Denies fever and chills.Given a single dose of im antibiotic and then prescribed oral antibiotics, had not felt any better, is still having pain in knee when trying to move it (pain).On (b)(6) 2022 after a latency of 6 days at the time of the phone call, the patient was having her right knee drained in the operating room (joint effusion).Action taken: drug withdrawn for all the events.Corrective treatment: a single dose of im antibiotic and then prescribed oral antibiotics for all the events.At time of reporting, the outcome was not recovered / not resolved for the event developed increased pain and swelling on sunday after the injection, was not recovered / not resolved for the event developed increased pain and swelling on sunday after the injection, was not recovered / not resolved for the event unable to bear weight, was not recovered / not resolved for the event was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted and was unknown for the event at the time of the phone call, the patient was having her right knee drained in the operating room.Seriousness criteria: medically significant, hospitalization for the event joint effusion and medically significant for rest of the events.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc (lot/batch number: arsp007 and expiry date: 31-mar-2023) with global ptc number: 100250044.The status of sample was requested & awaited and ptc is in progress.Additional information was received on 03-aug-2022 from other health professional from quality department.Strength was added.Ptc number was added.

Manufacturer Narrative

Sanofi company comment dated 08-aug-2022: this case involves a 54 years old female patient whose unable to bear weight, was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted., developed increased pain and swelling on sunday after the injection, developed increased pain and swelling on sunday after the injection and at the time of the phone call, the patient was having her right knee drained in the operating room while being treated with hylan g-f 20, sodium hyaluronate [synvisc].However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

Was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted [arthrocentesis] unable to bear weight [weight bearing difficulty] developed increased pain and swelling on sunday after the injection [injection site joint swelling] developed increased pain and swelling on sunday after the injection [injection site joint pain] ([pain upon movement]) at the time of the phone call, the patient was having her right knee drained in the operating room [effusion (r) knee] case narrative: initial information received on (b)(6) 2022 from united states regarding an unsolicited valid serious case received from the patient.This case involves a 54 years old female patient whose unable to bear weight, was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted, developed increased pain and swelling on sunday after the injection, developed increased pain and swelling on sunday after the injection and at the time of the phone call, the patient was having her right knee drained in the operating room while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2022, the patient received hylan g-f 20, sodium hyaluronate injection in her right knee at a dose of 2 ml once (lot - arsp007, expiry date: 31-mar-2023) having the strength 16mg/2ml (route: unknown) for osteoarthritis.Patient had a reaction to synvisc that took the patient to the er.The patient just followed up with the orthopedic surgeon and that the patient was going to the operating room to have the knee drained.Caller stated they don't know if something was wrong with the synvisc but that the patient's next few injections have been cancelled.Caller was requesting reimbursement.Is there something wrong with the batch? what was the return and reimbursement process? caller requests reimbursement for a kit of synvisc--they will not be using (b)(4) syringes since there was a severe reaction after the first syringe.The office had the other (b)(4) syringes from the kit.This was the first time their office has ever given synvisc to this patient.On (b)(6) 2022 after a latency of 3 days patient presents for an urgent visit was in the emergency room yesterday with failed aspiration attempted (aspiration joint), developed increased pain and swelling on sunday after the injection (injection site joint pain) (injection site joint swelling), unable to bear weight (weight bearing difficulty).Denies fever and chills.Given a single dose of im antibiotic and then prescribed oral antibiotics, had not felt any better, is still having pain in knee when trying to move it (pain).On (b)(6) 2022 after a latency of 6 days at the time of the phone call, the patient was having her right knee drained in the operating room (joint effusion).Action taken: drug withdrawn for all the events.Corrective treatment: a single dose of im antibiotic and then prescribed oral antibiotics for all the events.At time of reporting, the outcome was not recovered / not resolved for the event developed increased pain and swelling on sunday after the injection, was not recovered / not resolved for the event developed increased pain and swelling on sunday after the injection, was not recovered / not resolved for the event unable to bear weight, was not recovered / not resolved for the event was in the emergency room yesterday (b)(6) 2022 with failed aspiration attempted and was unknown for the event at the time of the phone call, the patient was having her right knee drained in the operating room.Seriousness criteria: medically significant, hospitalization for the event joint effusion and medically significant for rest of the events.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc (lot/batch number: arsp007 and expiry date: 31-mar-2023) with global ptc number: (b)(4).The status of sample was not received and the ptc stated: a product return was received; however, this is a medical complaint, and no further assessment of the syringe was needed at this time.Dp 21sep2022 the production and quality control documentation for arsp007 expiration date (2023-03) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the batch record review & lot frequency analysis for lot arsp007 no capa was required.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 has not indicated any safety issue.As of 20-sep-2022 there are (b)(4) complaints on file for lot arsp007 and all related sublots.(b)(4) complaints are on file for lot arsp007: (b)(4) leakage, (b)(4) leakage/adverse event report, (b)(4) broken syringe barrel and finger flange, (b)(4) adverse event report and (b)(4) air bubbles.Sanofi will continue to monitor complaints and trending to determine if a capa was required.The final investigation was completed on 13-oct-2022 with summarized conclusion as no assessment possible.Additional information was received on 03-aug-2022 from other health professional from quality department.Strength was added.Ptc number was added.Additional information was received on 13-oct-2022 from the quality department.Ptc details was added.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 15201266
• MDR Text Key: 297683640
• Report Number: 2246315-2022-00094
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Lot Number: ARSP007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/18/2022; 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Female