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

Lot Number U13021

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

Knee replacement [knee replacement].Bone problems [bone disorder].Initial information received on 09-mar-2022 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves 82 years old male patient who experienced knee replacement and bone problems while being treated with 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 30-oct-2014, the patient started taking hylan g-f 20, sodium hyaluronate injection (strength: 48 mg/6 ml), at the dose of 6 ml for once only (lot - u13021, 31-may-2016) for (indication, route: unknown).On the unknown date, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced bone problems (bone disorder) and had knee replacement (knee arthroplasty).Action taken: not applicable for both the events.It was not reported if the patient received a corrective treatment for the events (bone problems, knee replacement).Outcome: not recovered for both event.A product technical complaint (ptc) was initiated on 10-mar-2022 for synvisc-one (lot/batch number: u13021, 31-may-2016) with global ptc number: (b)(4).The sample status of the ptc was not available and the ptc stated that the production and quality control documentation for lot # u13021 expiration date (2016-05) 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 # u13021 no capa 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 28 mar 2022, a total of 46 complaints have been reported for lot # u1302 and all related sub-lots: 7 complaints have been reported for lot # u1302: (2) detached luer-lok hub, (1) tip breakage, (1) leaky syringe (2 syringes), (1) adverse event report, (1) tip breakage (1 syringe)/detached luer-lok hub (2 syringes) and (1) broken plunger rod/damaged lid/damaged tray (1 syringe).37 complaints have been reported for lot # u13021: (36) adverse event reports and (1) detached luer-lok hub.2 complaints have been reported for lot # u13022: (1) adverse event report and (1) broken plunger rod.Sanofi will continue to monitor complaints as stated in (b)(4) product event handling to determine if a capa is required.The final investigation was completed on 30-mar-2022 with summarized conclusion as no assessment possible.Reporter causality: not reported for both the events.Company causality: not reportable for both the events.Additional information was received on 30-mar-2022 from the quality department.Ptc details, strength and expiration date was added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 13995721
• MDR Text Key: 293842951
• Report Number: 2246315-2022-00037
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/04/2022

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 Expiration Date: 05/31/2016
• Device Lot Number: U13021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2022
• 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