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

Lot Number 9RSL014

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

Patient Problem Arthralgia (2355)

Event Type  Injury  

Event Description

Knee is still a little sensitive/pain, there are days when it is more painful than others [arthralgia aggravated].She has symptoms of fibromyalgia [fibromyalgia].Takes walks but is unable to take long walks/now able to walk, not fast nor for a very long time however she was not able to walk on it before [difficulty in walking].Sore legs [pain legs].Fall [fall].Swelling(left knee) [knee swelling].Case narrative: initial information was received on 02-oct-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "(b)(6)".Patient id: unknown; country: canada.Study title: (b)(6).This case is linked to case (b)(6) (multiple devices suspect for same patient).This case involves "an approximately" 61-year-old female patient who had fall, was taking walks but was unable to take long walks/now able to walk, not fast nor for a very long time however she was not able to walk on it before, sore legs, knee was still a little sensitive/pain, there are days when it is more painful than others, has symptoms of fibromyalgia and swelling(left knee) while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's family history was not provided.The patient started synvisc about 15 years ago because she had sore knees.It was years later when she had synvisc injected again.She had osteoarthrosis in her knee before receiving synvisc-one and was told to put cold packs on her knee and take tylenol, but there was no fibromyalgia diagnosed.Concomitant medications included vitamin d not otherwise specified and paracetamol (tylenol arthritis).On (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate injection, liquid (solution) in left knee at a dose of 6 ml once (strength: 48 mg/6 ml, batch number: 9rsl014 and expiry date: apr-2022, with an unknown route) for osteoarthritis.The patient reported that she was taking walks but was unable to take long walks (gait disturbance, unknown onset date and latency) and had sore legs (pain in extremity, unknown onset date and latency).Patient said that since her fall that was approximately two months ago (onset date: (b)(6) 2023, latency: approximately 3 years and 5 months) her knee was still a little sensitive (arthralgia, onset date: (b)(6) 2023, latency: approximately 3 years and 5 months).She was doing exercise and aqua form which had helped her knee.She was now able to walk, not fast nor for a very long time however she was not able to walk on it before (gait disturbance).Patient said she was a very big walker and now when she walks for thirty minutes or so she wants to sit down.The patient said she was taking tylenol for the pain (arthralgia) and in the beginning advil (anti-inflammatory) for the swelling (joint swelling, unknown onset date and latency).There were days when it was more painful than others (arthralgia), she would take a tylenol.She tried not to take too much medication.She said there was some weight, working as a hairdresser for 12 -14 years, working in a hospital (kitchen and housekeeping).Jobs that she was always on her feet.Patient said she was declared invalid.When she fell there were no x-rays taken when she went to emergency.They did however noticed she had osteoarthrosis in her knee and told her to put cold packs on her knee and take tylenol.Patient said there was probably fibromyalgia in her body as well but had not looked deeper into it.The patient does not recall the date as it happened about a year to a year and a half ago.The patient said that she had symptoms of fibromyalgia (onset date and latency: unknown), her treating physician said she was little, however had never had any tests done.Patient said she had received cortizone in her knee which did not help her.She was taking vitamin d, tylenol (when she has pain) and tylenol arthritis.The patient had both knees injected and the lot number and expiry date were the same.It was unknown if there were lab data/results available.Action taken: not applicable for all the events.Corrective treatment: hydrocortisone (cortizone), paracetamol (tylenol), exercise and aqua form for arthralgia and ibuprofen (advil) for joint swelling; not reported for rest of the events.At time of reporting, the outcome was recovering for the event gait disturbance, not recovered for pain in extremity, unknown for fall, fibromyalgia, arthralgia and joint swelling.Reporter causality: unassessable for gait disturbance, pain in extremity and fibromyalgia; not reported for rest of the events.Company causality: not reportable for all the events.Seriousness criteria: intervention required.A product technical complaint (ptc) was initiated on 02-oct-2023 for synvisc-one (lot/batch number: unknown) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.(em 13oct2023).Investigation (em 13oct2023): the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa(corrective and preventive actions) is required.The final investigation was completed on 13-oct-2023 with summarized conclusion as no assessment possible.Additional information was received on 13-oct-2023 from quality department via other healthcare professional: ptc details, results were added.Strength and formulation added for suspect.Text was amended.Additional information was received on 11-oct-2023 from patient: new events added: fall, arthralgia and joint swelling.As reported verbatim and event outcome for gait disturbance was updated.Patient age was added.Batch number and expiry date added for suspect.Medical history was added.Tylenol and advil added as corrective treatment.Clinical course was updated and text was amended.Additional information was received on 23-oct-2023 from patient: based on the information received the case initially processed as non serious case was upgraded to a serious case.Fibromyalgia was added as an event (previously captured as medical history).Concomitant medications were added.Cortisone added as corrective treatment for arthralgia.Clinical course was updated and text was amended.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• 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: 18041308
• MDR Text Key: 326989119
• Report Number: 2246315-2023-00102
• 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,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2023

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 Expiration Date: 04/01/2022
• Device Lot Number: 9RSL014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2023
• 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
• Treatment: TYLENOL ARTHRITIS (PARACETAMOL),UNKNOWN; VITAMIN D NOS (VITAMIN D NOS),UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Sex: Female