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

Lot Number CRSL039

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

Patient Problem Peripheral Edema (4578)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment follow-up dated 13-mar-2023: new follow-up does not change the previous assessment for this case.This case involves an unknown age male patient who reported edema after being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Based on the available information, causal relationship between the event and suspect product could not be excluded.However, further information regarding patient¿s medical history, past medications, concomitant medications, batch number, ptc results, injection technique, post injection routine, and other risk factors would aid in better case assessment.

Event Description

Edema (right knee) [edema knees].Increased swelling (right knee) [injection site joint swelling] ([condition worsened]).Extreme pain (right knee) [aching (r) knee].Case narrative: initial information received on 06-mar-2023 regarding an unsolicited valid serious case received from a patient from united states.This case was linked with (b)(4) (multiple device suspect used for the same patient).This case involves an unknown age male patient who reported edema, increased swelling, and extreme pain in right knee after being treated 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) and family history were not provided.Patient had both knees injected on (b)(4) 2022 with synvisc-one but didn't have this reaction.On (b)(4) 2023, the patient received hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 48 mg/6 ml) in right knee at a dose of 6 ml 1x (once), via intra-articular route (lot no.- crsl039, expiry date: (b)(4) 2025) for osteoarthritis.On (b)(4) 2023 after same day latency, the patient reported increased swelling (injection site joint swelling; condition aggravated) and extreme pain (arthralgia) and never had this reaction before.One knee was worse than the other knee.On (b)(4) 2023 after the latency of 14 days the patient was seen with noticed edema (oedema peripheral) given oral steroid medrol dose pack and had a steroid injection.Action taken: not applicable for all events.Corrective treatment: the patient was treated with methylprednisolone (medrol [methylprednisolone]) for oedema peripheral and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: intervention required for edema peripheral.A product technical complaint (ptc) was initiated on 06-mar-2023 for synvisc one (batch number: crsl039) with global ptc number: (b)(4).The investigation results are pending.Additional information was received on 06-mar-2023 from quality department via other healthcare professional.Suspect formulation, strength and global ptc number were added.Text amended accordingly.

Event Description

Edema (right knee) [edema knees] increased swelling (right knee) [injection site joint swelling] ([condition worsened]) extreme pain (right knee) [aching (r) knee] case narrative: initial information received on 06-mar-2023 regarding an unsolicited valid serious case received from a patient from united states.This case was linked with (b)(6) (multiple device suspect used for the same patient).This case involves an unknown age male patient who reported edema, increased swelling, and extreme pain in right knee after being treated 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) and family history were not provided.Patient had both knees injected on 19-aug-2022 with synvisc-one but didn't have this reaction.On (b)(6) 2023, the patient received hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 48 mg/6 ml) in right knee at a dose of 6 ml 1x (once), via intra-articular route (lot no.- crsl039, expiry date: 30-sep-2025) for osteoarthritis.On (b)(6) 2023 after same day latency, the patient reported increased swelling (injection site joint swelling; condition aggravated) and extreme pain (arthralgia) and never had this reaction before.One knee was worse than the other knee.On (b)(6) 2023 after the latency of 14 days the patient was seen with noticed edema (oedema peripheral) given oral steroid medrol dose pack and had a steroid injection.Action taken: not applicable for all events.Corrective treatment: the patient was treated with methylprednisolone (medrol [methylprednisolone]) for oedema peripheral and not reported for rest of the events.Outcome: unknown for all events.Seriousness criteria: intervention required for edema peripheral.A product technical complaint (ptc) was initiated on 06-mar-2023 for synvisc one (batch number: crsl039, expiry date: 30-sep-2025) with global ptc number: (b)(4).The sample status was not available.Based on the complaint from intake team, there is no quality related defect that would pose as a malfunction.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." defect class has been updated to ii and no pv# is currently provided - (dp (b)(6) 2023) the production and quality control documentation for lot # crsl039 expiration date (2025-09) was manufactured on 26oct22 packaged 16695 singles 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 # crsl039 no capa (corrective and preventive action) is required.As of (b)(6) 2023 there are 3 complaints on file for lot# crsl039 and all related sublots.3 complaints are on file for lot#crsl039: (2) adverse event reports and (1) syringe broken before use.Sanofi will continue to monitor adverse event to determine if a capa is required.The final investigation was completed on 17-apr-2023 with summarized conclusion as no assessment possible.Additional information was received on 06-mar-2023 from quality department via other healthcare professional.Suspect formulation, strength and global ptc number were added.Text amended accordingly.Additional information was received on 17-apr-2023 from quality department via other healthcare professional.Ptc results was added.Text amended accordingly.

• 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: 16563131
• MDR Text Key: 311482159
• Report Number: 2246315-2023-00021
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSL039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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