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

Lot Number 8RSP031B

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

Patient Problems Arthritis (1723); Arthralgia (2355); No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Event Description

Inflammation (left knee) [joint inflammation] ([arthralgia aggravated], [effusion (l) knee]).Case narrative: initial information received from (b)(6) on 10-nov-2020 regarding an unsolicited valid serious case received from a physician.This case involves an (b)(6)- year- old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and had inflammation (left knee).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 had ongoing stage 2 to 3 severity of left knee osteoarthritis, pain of the left knee, hypertension, and osteoporosis.On (b)(6) 2020, patient had no noticeable effusion before the administration of the first dose of hylan g-f 20, sodium hyaluronate; 2 ml.On the same day, the patient started using hylan g-f 20, sodium hyaluronate (8mg 3x2ml, formulation: not reported) at the dose of 2 ml, 3 doses at weekly interval via intra-articular route in left knee (lot - 8rsp031b) for oa (osteoarthritis) of the knee.On (b)(6) 2020, patient received last dose of hylan g-f 20, sodium hyaluronate.On (b)(6) 2020, after latency of 1 month 15 days, patient developed significant pain (arthralgia) and a mild effusion of the left knee (joint effusion) and the type of reaction was reported to be inflammation (arthritis).It was reported that the pain of the left knee was worse than before the intra-articular hylan g-f 20, sodium hyaluronate.Knee aspiration for the effusion was performed and 3 ml of straw colour fluid was aspirated.Intra-articular lidocaine hydrochloride (lignocaine) and triamcinolone were also administered.Event of arthritis and its symptoms were assessed as serious as intervention was required for the same.Action taken: no action taken.Corrective treatment: aspiration, lidocaine hydrochloride (lignocaine) and triamcinolone.Outcome: unknown.A product technical complaint was initiated and results were pending for the same.

Event Description

Inflammation (left knee) [joint inflammation] ([arthralgia aggravated], [effusion (l) knee]) case narrative: initial information received from singapore on 10-nov-2020 regarding an unsolicited valid serious case received from a physician.This case involves 81 years old female patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and had inflammation (left knee).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 had ongoing stage 2 to 3 severity of left knee osteoarthritis, pain of the left knee, hypertension and osteoporosis.On (b)(6) 2020, patient had no noticeable effusion before the administration of the first dose of hylan g-f 20, sodium hyaluronate; 2 ml.On the same day, the patient started using hylan g-f 20, sodium hyaluronate (8mg 3x2ml, formulation: not reported) at the dose of 2 ml, 3 doses at weekly interval via intra-articular route in left knee (lot - 8rsp031b; expiry date: 30-nov-2021) for oa (osteoarthritis) of the knee.On (b)(6) 2020, patient received last dose of hylan g-f 20, sodium hyaluronate.On (b)(6) 2020, after latency of 1 month 15 days, patient developed significant pain (arthralgia) and a mild effusion of the left knee (joint effusion) and the type of reaction was reported to be inflammation (arthritis).It was reported that the pain of the left knee was worse than before the intra-articular hylan g-f 20, sodium hyaluronate.Knee aspiration for the effusion was performed and 3 ml of straw colour fluid was aspirated.Intra-articular lidocaine hydrochloride (lignocaine) and triamcinolone were also administered.Event of arthritis and its symptoms were assessed as serious as intervention was required for the same.On an unknown date in 2020, the patient had recovered from the events after knee effusion was aspirated and intraarticular steroid/ lignocaine was administered.Action taken: no action taken.Corrective treatment: aspiration, lidocaine hydrochloride (lignocaine) and triamcinolone.Outcome: recovered.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2020 for product.Batch number: 8rsp031b.Device not returned.The production and quality control documentation for lot 8rsp031b expiration date nov-2021 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 8rsp031b 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 (b)(6) 2020 there are 2 complaints on file for lot# 8rsp031 and all related sub-lots.2 complaints are on file for lot# 8rsp031b: (1) syringe missing and (1) adverse event.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.Final investigation complete date: (b)(6) 2020.Additional information was received on 17-nov-2020 and 18-nov-2020 processed together with clock start date of 17-nov-2020 from healthcare professional and physician.Global ptc results added.Event outcome was updated.Expiry date added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10837208
• MDR Text Key: 217936747
• Report Number: 2246315-2020-00158
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Lot Number: 8RSP031B
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR