MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544)

Event Date 11/12/2021

Event Type  Injury  

Event Description

I had a durolane (bioventus) injection for knee pain on (b)(6) 2021.That day, i reported to md office that it felt like a bad bruise on the lower inside of my right knee.The left knee (also injected) felt fine.I understood there might be transient pain after injection, and it might take a few weeks for pre-injection discomfort to hopefully lessen, but it's 3 weeks later and my knee has gotten progressively worse.My quality of life is much worse than before the injection.My ability to walk is very hampered with constant limping.I cannot get through the night.Certainly, i had the knee treated because there were issues before, but it is now much worse than it was with constant pain on the inner joint.I have rested, iced, taken otc nsaids.All temporarily helped symptoms, but, again, it's worse day by day.Fda safety report id# (b)(4).

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 12953574
• MDR Text Key: 281927070
• Report Number: MW5105859
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/02/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Patient Sequence Number: 1
• Treatment: GABAPENTIN ; TAMSULOSIN
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White