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

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

Patient Problems Pain (1994); Swelling (2091); Vomiting (2144); Sweating (2444); Ambulation Difficulties (2544)

Event Date 07/09/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 i had durolane injections in both of knees for osteoarthritis.I've never had any food or med allergies to anything previously.The only medication i was on at the time was 50 mg tramadol for pain.I had previously had cortisone injections with no side effects.The injections were at 4 pm, by midnight, i was in extreme pain and it was very difficult to walk to the next room in my home just to use the bathroom.At 3:30 am i woke up in excruciating pain, sweating, puking, and had no use of my legs at all.I could not bend or lift them on my own.My husband took me to the er where they could do nothing for me but administer fluids and pain meds.I could not walk again until (b)(6) 2019 (3+ days later) and then i could only walk assisted by a walker.It's now (b)(6) 2019, 9 days after injections, and my legs are still swollen, in extreme pain, and i still cannot walk normal with my left leg.I am unable to climb any steps / stairs.I have been going to physical therapy, but my left leg is not improving.Did the problem stop after the person reduced the dose or stopped taking or using the product? no; did the problem return if the person started taking or using the product again? doesn't apply.

• Brand Name: DUROLANE
• Type of Device: ACID, HYLURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 8811412
• MDR Text Key: 151839623
• Report Number: MW5088262
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• 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): Hospitalization; Disability
• Patient Age: 47 YR
• Patient Weight: 92