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

Lot Number UNKNOWN

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

Patient Problems Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for follow up dated 23-dec-2020: follow up information does not change previous assessment of the case.This case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate and had an immune reaction characterized by sever joint swelling, pain and immobility.Based on the temporal gap; the causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s current medical condition, concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Immune reaction symptoms joint swelling, pain [immune-mediated adverse reaction] ([joint swelling], [joint pain]) immobility within 1 day following injection [immobile].Case narrative: initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from pharmacist through health authorities of united states under reference mw5097909.This case involves an unknown age patient who experienced immune reaction symptoms joint swelling, pain and immobility within 1 day following injection, while he/she was treated with hylan g-f 20, sodium hyaluronate (synvisc or synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.No information regarding concomitant medication was provided.On an unknown date in (b)(6) 2011, the patient started taking hylan g-f 20, sodium hyaluronate injection at an unknown dose and frequency via intra-articular route (with an unknown batch number) for unknown indication.On (b)(6) 2011, within 1 day of receiving the injection, the patient had severe joint swelling with immobility (immobile; seriousness criteria: medically significant, disability and required intervention).The patient was believed to have immune reaction (immune-mediated adverse reaction) with symptoms of joint swelling and pain.The event was reported to have caused serious injury with seriousness criteria of required intervention.Action taken: unknown for all events.It was not reported if the patient received a corrective treatment for all events.The patient outcome is reported as unknown for all events.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc for unknown batch number and global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review was not 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 ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.Investigation completion date: 23-dec-2020.Additional information was received on (b)(6) 2020 from healthcare professional.Investigational results were added.Text amended accordingly.

• Brand Name: SYNVISC
• 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: 11094461
• MDR Text Key: 229839214
• Report Number: 2246315-2020-00192
• 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: health professional
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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): Other; Required Intervention; Disability