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 Fever (1858); Pain (1994); Swelling (2091); Discomfort (2330); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 01/01/2017

Event Type  malfunction  

Event Description

This spontaneous case from united states was received on 23-jan-2018 from patient.This case concerns a (b)(6) male patient who initiated treatment with synvisc one and an the same day was uncomfortable, had fever, had swelling, saying "it was huge for 4 or 5 days; after unknown latency just hurts/pain and used crutches to get around, also, device malfunction was identified for the reported lot number.No medical history, previous medications, concomitant medications and concurrent conditions were reported.On an unknown date in 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once for left knee osteoarthritis (batch/ lot number: 7rsl021 and expiry date: unknown).On the same day, patient had pain that he described as discomfort.After receiving the injection he had swelling, saying it was huge for 4 or 5 days.He had a fever that he did not measure, saying he could tell he had a fever.The same day as the injection, he noted it was uncomfortable, but he was anticipating this.Patient was instructed to ice the knee and take ibuprofen.Then the next morning it was unbearable when he woke up.He used crutches to get around.He went to work the following day, and used crutches through the weekend.He currently can bear weight on the knee, but it just hurts and does not feel any better.He was not sure if the pain is the same or equal, but notice no help from the shot.Corrective treatment: crutches for crutches to get around; for ice the knee and ibuprofen swelling, saying "it was huge for 4 or 5 days and just hurts/pain; not reported for uncomfortable and fever.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 27-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced difficulty walking, and fever.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: 7250646
• MDR Text Key: 100261966
• Report Number: 2246315-2018-00243
• 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: 01/23/2018

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?: 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
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/08/2018
• 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: 48 YR
• Patient Weight: 100