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

Lot Number 9RSL043

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

Patient Problems Aspiration/Inhalation (1725); Arthralgia (2355)

Event Date 08/12/2020

Event Type  Injury  

Event Description

Knee pain (right) [aching (r) knee], knee joint effusion (right) [effusion (r) knee].Case narrative: this case is linked to case (b)(4) (same patient) (cluster).Initial information received on 10-sep-2020 from united states regarding an unsolicited valid serious case received from orthopedic technician.This case involves a (b)(6) years old male patient who experienced knee pain (right) and knee joint effusion (right), while he was treated 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.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection (48 mg/ 6 ml) at the dose of 6 ml via intra-articular route for once only in right knee (lot - 9rsl043) for oa (osteoarthritis).On the same day, patient experienced knee joint effusion (joint effusion) (life threatening, medically significant, hospitalization and intervention required) and knee pain (arthralgia) (life threatening, medically significant, hospitalization and intervention required).On (b)(6) 2020, that was very next day, patient had surgery, had right knee aspiration and was injected corticosteroids.Final diagnosis was knee joint effusion (right) and knee pain (right).Action taken: not applicable for both events.Corrective treatment: corticosteroids nos (corticosteroids), surgery and right knee aspiration for both the events.Outcome: unknown for both the events.

Event Description

Knee pain (right) [aching (r) knee].Knee joint effusion (right) [effusion (r) knee].Case narrative: this case is linked to case: (b)(4) (same patient) and (b)(4) (cluster).Initial information received on 10-sep-2020 from united states regarding an unsolicited valid serious case received from orthopedic technician.This case involves a 68 years old male patient who experienced knee pain (right) and knee joint effusion (right), while he was treated 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.On (b)(6) 2020, the patient started using hylan g-f 20, sodium hyaluronate injection (48 mg/ 6 ml) at the dose of 6 ml via intra-articular route for once only in right knee (lot: 9rsl043) for oa (osteoarthritis).On the same day, patient experienced knee joint effusion (joint effusion) (life threatening, medically significant, hospitalization and intervention required) and knee pain (arthralgia) (life threatening, medically significant, hospitalization and intervention required).On (b)(6) 2020, that was very next day, patient had surgery, had right knee aspiration and was injected corticosteroids.Final diagnosis was knee joint effusion (right) and knee pain (right).Action taken: not applicable for both events.Corrective treatment: corticosteroids nos (corticosteroids), surgery and right knee aspiration for both the events.Outcome: unknown for both the events.Product technical complaint (ptc) was initiated with global ptc number: 100081523 on 10-sep-2020 for product.Batch number: 9rsl043.The production and quality control documentation for lot: 9rsl043, expiration date sep-2022 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot: 9rsl043 no capa (corrective and preventive action) is 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 16-nov-2020, there are 4 complaints on file for lot#: 9rsl043 and all related sublots.4 complaints are on file for lot#: 9rsl043: (1) luer lok defect and (3) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa (corrective and preventive action) was required.Device not returned.Final investigation complete date: 17-nov-2020.Follow-up information was received with clock start date of 10-sep-2020 from other healthcare professional.Gptc number was added.No significant information was received.Additional information was received on 17-nov-2020 from healthcare professional.Global ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10539204
• MDR Text Key: 213856177
• Report Number: 2246315-2020-00134
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 9RSL043
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Weight: 100