MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Lot Number R13626A

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Inflammation (1932); Ambulation Difficulties (2544)

Event Date 07/31/2020

Event Type  Injury  

Event Description

The patient had a severe inflammatory reaction to euflexxa a hyaluronic acid injection.This is a known possible side effect.However, the inflammatory reaction usually subsides within a few weeks.However, the inflammatory reaction has been permanent.I reached out to the company that manufactures euflexxa and they said they would test the lot, but i have not been able to get a response despite multiple inquiries.She and multiple joint aspirations and cortisone injections, which did not improve her symptoms.The patient tried arthroscopic knee surgery, which did not improve her symptoms.All infectious markers and cultures have been negative.She is seeing a rheumatologist which is treating for an inflammatory condition.However, she will has made little progress.She has not been able to walk for almost a year now and she will likely need a left knee replacement and right toe fusion, but she will likely have lifelong disability from this issue.Injection material: lot# r13626a, exp-03/28/2021.

Event Description

Additional information received from reporter for report mw5101620 on 11/03/2022.Patient has positive test for a fungal infection at the injection site, patient is still unable to walk as her knee is completely destroyed.The infection is due to a contaminate that is found in injectables.He has tried several times to reach the manufacturer and the manufacturer has not been helpful with finding a resolution to the problem.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 11912412
• MDR Text Key: 253713783
• Report Number: MW5101620
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/28/2021
• Device Lot Number: R13626A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White