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

Lot Number 9RSL001ZE

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

Patient Problems Erythema (1840); Headache (1880); Unspecified Infection (1930); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Type  Injury  

Event Description

Thinks that she has infection as her knee is so red, her knee is swollen, very painful [joint infection].Getting very depressed [depressed state].Tried to do exercise yesterday but it got more worse and she barely can walk [difficulty in walking].A terrible headache and a lot of pain [headache].Terrible headache and lot of pain (right knee)/ knee feels quite stiff, sore, and painful (more than before)/pain was localized inside knee before but goes through whole knee now (generalized)/still same problem and getting worse/very painful [injection site joint pain] ([condition worsened], [product administered at inappropriate site]).Knee feels quite stiff, sore, and painful (more than before).[stiff knees] ([condition aggravated]).Thinks that she has infection as her knee is so red, her knee is swollen, very painful [injection site joint swelling].Thinks that she has infection as her knee is so red, her knee is swollen, very painful [injection site joint redness].Case narrative: based on the additional information received on 15-jan-2021 from a patient, this case previously processed as non-serious was upgraded to serious due to event of arthritis infective which was assessed as medically significant.Initial information received on 16-dec-2020 from canada regarding an unsolicited valid serious case from a patient.This case involves a (b)(6) years old female patient who thinks that she has infection as her knee is so red, her knee is swollen, very painful (arthritis infective, injection site joint swelling, injection site joint erythema), getting very depressed, tried to do exercise yesterday but it got more worse and she barely can walk, terrible headache and lot of pain (right knee)/ knee feels quite stiff, sore, and painful (more than before)/pain was localized inside knee before but goes through whole knee now (generalized)/still same problem and getting worse/very painful (headache, injection site joint pain, joint stiffness), with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history included mild heart attack that required stints (myocardial infarction) in (b)(6) 2020, previous surgery on her knee 6 years ago in 1994 due to a torn meniscus and is trying to avoid another knee surgery.Patient received three synvisc injections approx.7 years ago.The patient's past vaccination(s) and family history were not provided.Concomitant medications included cortisone.The patient had synvisc one injection right knee in (b)(6) 2020.After the first injection, the patient had a lot of relief after 2 days and it lasted approximately 8 months.On (b)(6) 2020, the patient used hylan g-f 20, sodium hyaluronate, solution for injection at dosage of 6 ml once (lot - 9rsl001ze, 30-nov-2021) in right knee for osteoarthritis (route: unknown).This time, the injection was given by an intern and observed by the md.It was guided by ultrasound but did not feel the same going in.The product was injected in the outside edge under the knee cap (product administered at inappropriate site).On the next day (latency 1 day), the patient had a terrible headache and a lot of pain (headache).On an unknown date in (b)(6) 2020, the patient's knee felt quite stiff, sore, and painful (more than before) and pain was localized inside the knee before but goes through the whole knee now (generalized) (injection site joint pain, joint stiffness and condition aggravated).The patient was very concerned and thought it may be caused by the administration as it was the only factor that was different.The patient had taken tylenol arthritis, but relief was not substantial, and she could not take advil as she gets a rapid heart rate with it.Patient also applied a topical anti-inflammatory analgesic that gave some relief.The pain waked her up at night and she was getting very depressed (depression, start date, latency unknown).Patient was unable to exercise or take part in the cardiac rehab program as it would exacerbate the pain.The patient asked if the way the injection was administered make a difference on the effectiveness and if other people had this experience.The patient if there was some timeframe of how long this was supposed to last.On (b)(6) 2021, after latency of 1 month 10 days, she tried to do exercise, but knee got more worse and she could barely walk (gait disturbance).On (b)(6) 2021, she stated that she still had the same problem and was getting worse (condition aggravated).She thought that she had infection (arthritis infective; assessed as medically significant; latency: unknown) as her knee was so red (injection site joint erythema), swollen (injection site joint swelling), and was very painful (injection site joint pain).Her doctor prescribed to her topical compound cream, also tylenol arthritis but nothing was working for her.Action taken: not applicable for all events.The patient was treated with topical anti-inflammatory analgesic, topical compound cream, paracetamol (tylenol arthritis) for injection site joint swelling, injection site joint erythema and injection site joint pain, joint stiffness; not reported for rest of events.The patient outcome is reported as not recovered for all the events.A product technical complaint was initiated on 16-dec-2020 for synvisc one.Batch number: 9rsl001ze global ptc number: (b)(4).The production and quality control documentation for lot 9rsl001ze expiration date (2021-11) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl001ze no capa (corrective and preventive action) 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 had not indicated any safety issue.As of 04-jan-2021 there were 3 complaints on file for lot 9rsl001z and all related sublots.1 complaint was on file for lot 9rsl001zc: (1) expiration dating.2 complaints were on file for lot 9rsl001ze: (2) adverse event reports.Sanofi would continue to monitor if a capa is required.Investigation complete date: 05-jan-2021.Additional information was received on 05-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Additional information was received on 15-jan-2021 from a patient.Case was upgraded to serious due to event of arthritis infective.Events added- thinks that she has infection as her knee is so red, her knee is swollen, very painful (arthritis infective, injection site joint swelling, injection site joint erythema).Clinical course was updated.Symptom-condition aggravated added for injection site joint pain.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 11222129
• MDR Text Key: 231669589
• Report Number: 2246315-2021-00032
• 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
• Report Date: 01/25/2021

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
• Device Expiration Date: 11/30/2021
• Device Lot Number: 9RSL001ZE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2021
• 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): Other; Required Intervention