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

Lot Number 8RSL062

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 20-nov-2023: this case involves an adult male patient who had pain, accident with a trailer and few good falls while being treated with the use of medical device hylan g-f 20, sodium hyaluronate.Based on the limited information provided regarding this case, causal role of the company suspect product can be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Pain [pain]; accident with a trailer [motor vehicle accident] ; few good falls [fall] ; case narrative: initial information received on 13-nov-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves adult male patient who had pain, accident with a trailer and few good falls while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one] the patient's past medical treatment(s), concomitant medication(s) and family history were not provided.Patient mentioned that he was on long term disability for his lower back, both shoulders.He did not receive a synvisc injection in quite some time.He had surgery twice in the right shoulder and that threw him off work not being able to lift enough.On (b)(6) 2019, the patient started taking hylan g-f 20, sodium hyaluronate injection in right knee at a dose of 6 ml once (with unknown strength, route and expiry date; lot number: 8rsl062) for osteoarthritis.On an unknown date and latency, after a few good falls (fall) and had an accident with a trailer (road traffic accident) he had been in pain ever since (pain; seriousness criteria: intervention required).He has had cortizone shots since and they do not work.Action taken: not applicable for all the events.The patient was treated with hydrocortisone (cortizone) for pain and not reported for rest events at time of reporting, the outcome was not recovered for all the events.Reporter causality: not reported for all events.Company causality: not reportable for all events.

Event Description

Pain [pain].Accident with a trailer [motor vehicle accident].Few good falls [fall].Case narrative: initial information received on 13-nov-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case is linked to case: (b)(4) (multiple devices suspect for same patient).This case involves adult male patient who had pain, accident with a trailer and few good falls while being treated with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.Patient mentioned that he was on long term disability for his lower back, both shoulders.He did not receive a synvisc injection in quite some time.He had surgery twice in the right shoulder and that threw him off work not being able to lift enough.On (b)(6) 2019, the patient started taking hylan g-f 20, sodium hyaluronate injection in right knee of strength: 48mg/6ml, at a dose of 6 ml once (with unknown route; lot number: 8rsl062 and expiry date: 30-sep-2021) for osteoarthritis.On an unknown date and latency, after a few good falls (fall) and had an accident with a trailer (road traffic accident) he had been in pain ever since (pain; seriousness criteria: intervention required).He has had cortizone shots since and they do not work.Action taken: not applicable for all the events.The patient was treated with hydrocortisone (cortizone) for pain and not reported for rest events.At time of reporting, the outcome was not recovered for all the events.Reporter causality: not reported for all events.Company causality: not reportable for all events.A product technical complaint (ptc) was initiated on 13-nov-2023 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: 8rsl062 and expiry date: 30-sep-2021) with global ptc number: (b)(4).The sample was not available and 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 - (dp 15nov2023).The production and quality control documentation for lot#: 8rsl062, expiration date (2021-09) was manufactured on 18oct2018 packaged (b)(4) singles was reviewed.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#: 8rsl062 no capa is required.As of 16nov2023, there are 7 complaints on file for lot#: 8rsl062 and all related sub-lots.There are 5 complaints on file for lot#: 8rsl062: (5) adverse event reports.1 complaint is on file for lot#: 8rsl062b: (1) expiry date.1 complaint is on file for lot#: 8rsl062a: (1) missing component.Sanofi will continue to monitor complaints and trending as "product event handling'' to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 01-dec-2023 with summarized conclusion as no assessment possible.Additional information was received on 01-dec-2023 from quality department: ptc details with summarized conclusion, suspect strength and expiry date added.Text was amended accordingly.

• 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: 18190437
• MDR Text Key: 328779373
• Report Number: 2246315-2023-00108
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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: 09/30/2021
• Device Lot Number: 8RSL062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male