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

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 01/01/2021

Event Type  Injury  

Event Description

I had durolane injection in right knee (b)(6) 2021 (not sure of day) for osteoarthritis.Had horrible pain few days later, continued into (b)(6).Went to dr and told him about this.He took x-ray and said everything looked the same as last x-ray.Suggested pain was from my back.Did not have pain before injection.Pain in calf was excruciating in (b)(6), went to primary dr and she ordered an ultrasound to make sure it was no a blood clot.Negative.It is now the middle of (b)(6) 2021 and i am in more pain than before injection.(knee & calf all the way to top of foot.I can not sleep, walk or socialize due to worsening of pain.I have heard from other people that they have experienced similar reaction.I dont think this is a good product.Are you aware of this side effect/ negative reaction? what, if anything can i do to get back to normal? normal being just knee pain.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 12662575
• MDR Text Key: 277664518
• Report Number: MW5104745
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 99