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

Lot Number UNKNOWN

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

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Pain [pain].Accident with a trailer [motor vehicle accident].Few good falls [fall].Case narrative: initial information received on (b)(6) 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 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), vaccination(s) and family history were not provided.Patient mentioned that he was on long term disability for his lower back, both shoulders and his left knee.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.The patient had on ongoing knee osteoarthritis.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6ml in the left knee via intra-articular for knee osteoarthritis and it worked (unknown dose, frequency, batch number and expiry date).Information on batch number and expiry date was requested 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.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 the event pain, was unknown for rest events.Reporter causality: not reported for all events.Company causality: not reportable for all events.

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2023: 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.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 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), vaccination(s) and family history were not provided.Patient mentioned that he was on long term disability for his lower back, both shoulders and his left knee.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.The patient had on ongoing knee osteoarthritis.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6ml in the left knee via intra-articular for knee osteoarthritis and it worked (unknown dose, frequency, batch number and expiry date).Information on batch number and expiry date was requested.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.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 the event pain, was unknown for rest events.A product technical complaint (ptc) was initiated on 13-nov-2023 for synvisc one (batch number: unknown) with global ptc number: 100376878.The sample status was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there was 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.(15nov2023) investigation (15nov2023).The product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis to determine if a capa (corrective and preventive action) was required.The final investigation for the ptc was completed on 15-nov-2023 with summarized conclusion as 'no assessment possible'.Reporter causality: not reported for all events.Company causality: not reportable for all events.Additional information was received on 15-nov-2023 from quality department via other healthcare professional.Global ptc number and ptc results were added and text 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: 18157615
• MDR Text Key: 328353239
• Report Number: 2246315-2023-00107
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

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 Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2023
• 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