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

Lot Number 7RSL021

Device Problem Microbial Contamination of Device (2303)

Patient Problems Thrombosis (2100); Anxiety (2328); Injury (2348); No Code Available (3191)

Event Date 11/18/2017

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment 06-mar-2019.Patient developed deep venous thrombosis, severe and permanent disabling injuries after receiving synvisc one injection from the recall lot.A temporal relationship can be established with the product administration.Furthermore, the concerned lot number has been identified to have malfunction by the company.Therefore, the causal relationship of the events to the products cannot be excluded.

Event Description

Deep venous thrombosis [deep vein thrombosis] ([pain]); severe and permanent disabling injuries [permanent injury]; device malfunction [device malfunction]; mental and emotional anxiety [anxiety]; case narrative: this case is cross referenced to case (b)(4) (multiple devices).Initial information received on 27-feb-2019 from united states regarding an unsolicited valid serious case received from lawyer.This case involves an adult male patient who experienced deep venous thrombosis, severe and permanent disabling injuries, mental and emotional anxiety, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).Additionally, event of device malfunction was added for the identified recall lot.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2017, the patient received intra-articular injection of hylan g-f 20, sodium hyaluronate at 6ml once (batch: 7rsl021) for chronic osteoarthritis in both of his knees.On (b)(6) 2017, patient experienced a severe adverse reaction (latency: 1 day) that required immediate medical intervention.The patient reported to the medical center the same day and an ultrasound of patients left calf was performed which revealed deep venous thrombosis (latency: 1 day) in his left tibial vein and left perineal vein.As a result of this the patient had acute and excruciating pain and was admitted to the hospital on (b)(6) 2017.The patient was closely monitored and evaluated by specialists and sustained severe and permanent disabling injuries (latency: 1 day).On (b)(6) 2017, patient was discharged from the hospital and suffered mental and physical anxiety (latency: unknown).Corrective treatment: not reported.Outcome: unknown for mental and physical anxiety; not recovered for rest.Seriousness criterion: hospitalization for deep venous thrombosis, disability for severe and permanent disabling injuries; medically significant for deep venous thrombosis and device malfunction.An investigation summary was initiated as a result of an unexpected increase in the number of labeled adverse events received from us market for synvisc-one lot 7rsl021.The product met all release testing at time of manufacture in june 2017.Retain samples were retested due to the unexpected increase in adverse events.Higher than expected endotoxin results were obtained.In addition, the presence of microbial contamination was also confirmed.The cause of these events is under investigation.Once this investigation is completed, corrective and preventive actions will be implemented.

• 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: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 8402998
• MDR Text Key: 138226090
• Report Number: 2246315-2019-00075
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Other; Disability