MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL021

Device Problem Device Contamination With Biological Material (2908)

Patient Problems Headache (1880); Pain (1994)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 02-jan-2018 from the patient this case concerns a (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency experienced headaches, neck pain, light headedness, little puffiness after injection and little soreness after injection, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On (b)(6) 2017, patient received treatment with intra articular synvisc one injection (dose, frequency and indication: not provided).On an unknown date in (b)(6) 2017, after an unknown latency, there was always a little puffiness and soreness after the injection.She also saw some headaches and neck pain.She has also noticed light headedness at different times, usually an overnight thing where she did not have balance and that had happened several times since the injection (onset: (b)(6) 2017; latency: unknown).Corrective treatment: not reported for all events.Outcome: not recovered for all events.Seriousness criteria: important medical event for device malfunction an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the 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 pharmacovigilance comment: sanofi company comment dated 09-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot in her right knee and had little puffiness and soreness after the injection, light headedness, neck pain and headaches.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.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7214724
• MDR Text Key: 98429464
• Report Number: 2246315-2018-00101
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 7RSL021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR