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

Lot Number ARSP001B

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

Patient Problem Synovitis (2094)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Synovitis post infiltration (right knee) [injection site synovitis].Case narrative: initial information was received on 24-jul-2023 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves 79 years old female patient who had synovitis post infiltration (right knee) while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.It is unknown if the patient had any medical history, concomitant disease or risk factor.At the time of the event, the patient had ongoing chondrocalcinosis.Since 2009, the patient had synvisc annually and never had a problem (despite chondrocalcinosis).On (b)(6) 2021, the patient received hylan g-f 20, sodium hyaluronate injection, liquid (solution) in right knee(lateral injection) at dose of 2ml three times via route intra-articular (lot - arsp001b, expiry date: 31-jan-2023, strength: 16mg/2ml) for osteoarthritis grade iv on an unknown date in 2021, unknown latency, the patient had a reaction on their last synvisc injection which was described as synovitis post infiltration (injection site joint inflammation) (intensity: moderate).Synvisc contributed to the adverse event as per reporter.Also, adverse event reported was related to the patient's pre-existing condition.It is unknown if there were lab data/results available.Action taken: not applicable corrective treatment: corticosteroids(unspecified) at time of reporting, the outcome was recovered on an unknown date reporter causality: related company causality: reportable seriousness criteria: intervention required a product technical complaint (ptc) was initiated on (b)(6) 2023 (ptc start date) for synvisc-one (lot/batch number: arsp001b, expiry date: 31-jan-2023) with global ptc number: (b)(4).The sample of the ptc was not available and the ptc stated: complaint: adverse event preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, 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.(tj (b)(6) 2023) the production and quality control documentation for lot # arsp001b expiration date (2023-01) was manufactured on 26feb2020 packaged 444 singles were 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 # arsp001b no capa (corrective and preventive actions) is required.As of (b)(6) 2023 there are 3 complaints on file for lot# arsp001 and all related sublots.2 complaint is on file for lot# arsp001b: (2) adverse event reports.1 complaint is on file for lot# arsp001e: (1) adverse event report.Sanofi will continue to monitor complaints and trending to determine if a capa was required.The final investigation was completed on (b)(6) 2023 (closed ptc date) with summarized conclusion as no assessment possible.Additional information was received on 16-aug-2023 from healthcare professional (quality department).Ptc number for lot number: arsp001b along with strength was added.Text amended accordingly.Additional information was received on 15-aug-2023 from healthcare professional (quality department): ptc results were added.Expiry date was added.Text was amended.Additional information was received on 16-aug-2023 from other health care professional: based on this information, the case initially considered as non-valid non-serious case was upgraded to valid serious case; based upon the additional information received the case has been updated to medically confirmed.Event of adverse reaction to product deleted; event of injection site joint inflammation added; indication updated; medical history updated; the corresponding tabs and the narrative updated and the text amended accordingly.

• Brand Name: SYNVISC
• 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: 17604187
• MDR Text Key: 321753521
• Report Number: 2246315-2023-00092
• 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,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2023

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 Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Lot Number: ARSP001B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2023
• 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: Female