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

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

Patient Problems Angina (1710); Unspecified Hepatic or Biliary Problem (4493); Angioedema (4536)

Event Type  Injury  

Event Description

Ludwig angina [ludwig angina].Angioedema [angioedema].Liver transplantation [liver transplantation].Right knee pain/worsening [arthralgia aggravated].Left knee pain [aching (l) knee].Case narrative: initial information was received on 20-nov-2018 from united states regarding an unsolicited valid serious legal case from a lawyer.This case involves a (b)(6) years old male (177 cm and (b)(6) kg) patient who experienced angioedema, ludwig angina, liver transplantation, right knee pain/worsening and left knee pain, while he was treated with medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history included syphilis, cirrhosis of liver, hepatitis c infection, hyperplastic colon polyp, osteoarthritis, appendicectomy in 1976, oesophagogastroduodenoscopy on (b)(6) 2018, left heart cath in (b)(6) 2011, hand and back pain, fall due to pain, ambulating with cane, carpal tunnel syndrome, right neck mass and alcohol use with quit drinking over 20 years ago.The patient's family history included arthritis, coronary artery disease and diabetes mellitus.The patient's past medical treatment(s), vaccination(s) was not provided.At the time of the event, the patient was current tobacco user with 1 pack/day for 10 years, had asthma, chronic obstructive pulmonary disease, and hypertension.Concomitant medications included sildenafil; lactulose (cephulac); enalaprilat (vasotec); celecoxib (celebrex); pantoprazole; tramadol; spironolactone (aldactone); salbutamol sulfate (albuterol); ipratropium; and clindamycin.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate, injection, via intraarticular route (dosage and frequency, lot number, and indication: unknown).There will be no information available on the batch number of this case.On an unknown date, after unknown latency, patient was listed for liver transplantation (liver transplant).Patient had bilateral knee pain (arthralgia).Pain localize to the medial and lateral jointline of the left knee.The pain of the right knee is located at the lateral joint line.It had been present for 1 year and had been worsening.Aggravating factors including ambulation.From (b)(6) 2017, patient was admitted to hospital for ludwig angina and angioedema.Relevant laboratory test results included: x-ray - on an unknown date: diffuse osteophytosis of the bilateral knee with severe joint space narrowing and tibial sclerosis.Action taken: unknown for all events.Corrective treatment: tramadol for right knee pain/worsening and left knee pain; not reported for the rest of the events.Outcome: unknown for all events.Pending a product technical complaint (ptc) was initiated on 20-nov-2018 for synvisc; batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformance) process.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.Sanofi will continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa is required.Final investigation was completed on (b)(6) 2021.Follow up information received on 20-nov-2018 from healthcare professional.Global ptc number added.Additional information was received on (b)(6) 2021 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.Follow up information received on 03-jun-2021 from other healthcare professional.The complaint (b)(4) for usa has been reopened for the following reason: incomplete complaint information.

• 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: 11975938
• MDR Text Key: 267541818
• Report Number: 2246315-2018-00879
• 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
• Report Date: 06/08/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2021
• 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): Hospitalization; Other; Required Intervention
• Patient Weight: 64