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

Lot Number ARSL024C

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Underwent fluid withdrawal from the joint for symptomatic relief (knee) [knee effusion] ([painful knee], [knee swelling]).Underwent fluid withdrawal from the joint for symptomatic relief (knee) [arthrocentesis].Case narrative: initial information received from macao on 28-apr-2021 regarding an unsolicited valid serious case received from a orthopedic doctor.This case is linked to cases (b)(4) (cluster cases) this case involves adult and unknown gender patient who underwent fluid withdrawal from the joint for symptomatic relief (knee) after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (lot, dose, frequency, route, indication - unknown).Information on the batch number was requested.On an unknown date, after unknown latency, patient had painful knee joint and serious swelling around 1-2 days after synvisc one injection and underwent fluid withdrawal from the joint for symptomatic relief (join effusion, joint swelling, arthralgia, aspiration joint).All the event assessed as serious due to required intervention.Action taken: not applicable for both events.Corrective treatment: fluid withdrawal.At time of reporting, the outcome was not applicable for aspiration joint and was unknown for joint effusion.A product technical complaint was initiated and results were pending for the same.

Event Description

Underwent fluid withdrawal from the joint for symptomatic relief (knee) [knee effusion] ([painful knee], [knee swelling]) underwent fluid withdrawal from the joint for symptomatic relief (knee) [arthrocentesis].Case narrative: upon internal review on 07-may-2021, case (b)(4) was identified as duplicate of case (b)(4).Hence, all the information was retained in case (b)(4).Case (b)(4) received with clock start date of 29-apr-2021 would be deleted.Initial information was received from macao on 28-apr-2021 regarding an unsolicited valid serious case received from an orthopedic doctor.This case is linked to cases (b)(4) (duplicate), (b)(4) (cluster cases).This case involves adult and unknown gender patient who underwent fluid withdrawal from the joint for symptomatic relief (knee) after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, indication - unknown) (batch number arsl024c) for unknown indication.On an unknown date, around 1-2 days after synvisc one injection, patient had painful knee joint and serious swelling and underwent fluid withdrawal from the joint for symptomatic relief (join effusion, joint swelling, arthralgia, aspiration joint).All the event assessed as serious due to required intervention.Reportedly, as the complaint sample had been discarded by the doctor, the doctor had provided one remaining synvisc product (same batch at his clinic; arsl024c) for further investigation.Action taken: not applicable for both events.Corrective treatment: fluid withdrawal.At time of reporting, the outcome was not applicable for aspiration joint and was unknown for joint effusion.A product technical complaint was initiated with global ptc number (b)(4) and results were pending for the same.Additional information was received on 29-apr-2021 from a physician.Batch number and gptc number was added.Text amended accordingly.Also, upon internal review on 07-may-2021, case (b)(4) was identified as duplicate of case (b)(4).Hence, all the information was retained in case (b)(4).Case (b)(4) received with clock start date of 29-apr-2021 would be deleted.

Event Description

Underwent fluid withdrawal from the joint for symptomatic relief (knee) [knee effusion] ([painful knee], [knee swelling]) underwent fluid withdrawal from the joint for symptomatic relief (knee) [arthrocentesis].Case narrative: upon internal review on 07-may-2021, case (b)(4) was identified as duplicate of case (b)(4).Hence, all the information was retained in case (b)(4).Case (b)(4) received with clock start date of 29-apr-2021 would be deleted.Initial information was received from macao on 28-apr-2021 regarding an unsolicited valid serious case received from an orthopedic doctor.This case is linked to cases (b)(4) (cluster cases).This case involves adult and unknown gender patient who underwent fluid withdrawal from the joint for symptomatic relief (knee) after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (dose, frequency, route, indication - unknown) (batch number arsl024c; expiration date: nov-2023) for unknown indication on an unknown date, around 1-2 days after synvisc one injection, patient had painful knee joint and serious swelling and underwent fluid withdrawal from the joint for symptomatic relief (join effusion, joint swelling, arthralgia, aspiration joint).All the event assessed as serious due to required intervention.Reportedly, as the complaint sample had been discarded by the doctor, the doctor had provided one remaining synvisc product (same batch at his clinic; arsl024c) for further investigation.Action taken: not applicable for both events corrective treatment: fluid withdrawal.At time of reporting, the outcome was not applicable for aspiration joint and was unknown for joint effusion.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 29-apr-2021 for product.Batch number: arsl024c.Device not returned.The production and quality control documentation for lot arsl024c expiration date nov-2023 was reviewed.The investigation showed that the product met specifications.No associated nonconformances were noted.Based on the lot batch record review & lot frequency analysis for lot arsl024c no capa (corrective and preventive action) is 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 has not indicated any safety issue.As of 10-may-2021 there are 3 complaints on file for lot# arsl024 and all related sublots.3 complaints are on file for lot# arsl024c: (3) adverse event reports.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa (corrective and preventive action) was required.Final investigation complete date: 10-may-2021.Additional information was received on 29-apr-2021 from a physician.Batch number and gptc number was added.Text amended accordingly.Also, upon internal review on 07-may-2021, case (b)(4) was identified as duplicate of case (b)(4).Hence, all the information was retained in case (b)(4).Case (b)(4) received with clock start date of 29-apr-2021 would be deleted.Additional information was received on 10-may-2021 from healthcare professional.Global ptc results and number added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11775679
• MDR Text Key: 264404651
• Report Number: 2246315-2021-00099
• 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,Followup,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Lot Number: ARSL024C
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention