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 Problems Arthritis (1723); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 31-jul-2023: this case involves adult patient of unknown gender whose joint became inflamed and send cultures away for testing with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect product in causing the reported events cannot be denied.Case will be re-evaluated post further update on the onset latency, injection technique, post injection routine, batch number details and investigation results, patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Joint became inflamed [injection site joint inflammation] ([injection site joint swelling], [injection site joint redness], [injection site joint pain]).Send cultures away for testing [arthrocentesis].Case narrative: initial information received from south africa on 08-mar-2022 regarding an unsolicited valid serious case received from a physician.This case is linked to case (b)(4) (cluster).This case involves adult patient of unknown gender whose joint became inflamed and send cultures away for testing with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medication(s), concomitant disease, risk factor and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (with unknown strength, dose, frequency, route, indication, batch number and expiry date).Information on batch number was requested.On the unknown date, after the unknown latency, patient's joint became inflamed (injection site joint inflammation), joint swelled up (injection site joint swelling), joint became red (injection site joint erythema) and joint became painful (injection site joint pain) and send cultures away for testing (arthrocentesis), but it came back negative for any infections.Relevant laboratory test results included: aspiration joint - on an unknown date: negative.Action taken: unknown for all the events.It was not reported if the patient received a corrective treatment for all the events.Outcome: not recovered / not resolved for all the events.Seriousness criteria: intervention required for all the events.

Event Description

Joint became inflamed [injection site joint inflammation] ([injection site joint swelling], [injection site joint redness], [injection site joint pain]) send cultures away for testing [arthrocentesis] case narrative: initial information received from south africa on 08-mar-2022 regarding an unsolicited valid serious case received from a physician.This case is linked to case (b)(4) (cluster).This case involves adult patient of unknown gender whose joint became inflamed and send cultures away for testing with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant medication(s), concomitant disease, risk factor and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection of strength 48 mg/6 ml (with unknown dose, frequency, route, indication, batch number and expiry date).Information on batch number was requested.On the unknown date, after the unknown latency, patient's joint became inflamed (injection site joint inflammation), joint swelled up (injection site joint swelling), joint became red (injection site joint erythema) and joint became painful (injection site joint pain) and send cultures away for testing (arthrocentesis), but it came back negative for any infections.Relevant laboratory test results included: aspiration joint - on an unknown date: negative.Action taken: unknown for all the events.It was not reported if the patient received a corrective treatment for all the events.Outcome: not recovered / not resolved for all the events.Seriousness criteria: intervention required for all the events.A product technical complaint (ptc) was initiated on 08-mar-2022 for synvisc one.Batch number; unknown global ptc number: 100345161.Sample status of ptc was not received , and ptc stated complaint: adverse event 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.(em 24jul2023.(em 24jul2023).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.Sanofi will continue to monitor adverse events to determine if a capa(corrective and preventive actions) was required.The final investigation was completed on 24-jul-2023 with summarized conclusion as no assessment possible additional information was received on 24-jul-2023 by quality department: ptc complete details added; suspect updated from synvisc to synvisc one; strength added; text amended.

• 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: 17443988
• MDR Text Key: 320239812
• Report Number: 2246315-2023-00084
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2023
• 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