MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE HYALURONIC ACID, STABILIZED SINGLE SHOT INJECTION; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Diarrhea (1811); Headache (1880); Pain (1994); Ambulation Difficulties (2544)

Event Date 06/23/2022

Event Type  Injury  

Event Description

Thursday, june 23, i received durolane gel injections in both of my knees.The shots themselves were painful but this was especially so in one knee, and i limped out of the doctor's office.Starting about 2 hours after the injections, i couldn't even walk and had to use crutches.After 2 days, i could walk on my own again, but i couldn't get up from a sitting position and couldn't sit down without help, it was much worse than before the injections.I also couldn't get up or down the stairs without the help of my husband, going very slowly and leaning most of my weight on the stair railing.It was excruciatingly painful.When i lifted my knee up and down to drive which wasn't a problem before the injections at all, it was so painful that i couldn't drive safely for a week and a half.I still am driving only very short distances.At this point, 14 days after injections, my knees are still sore, getting up and down is much harder than it was before the injections as is walking up and down the steps.The emotional toll has been great.I've been so scared that i will end up worse off than i was before the injections.I also have had to spend most of my time off my feet and so i'm behind in all i had planned to do.If you look at patient reviews, you will see that i'm far from being alone.This drug should be investigated.Today, i have diarrhea and a headache.I have no idea if today's symptoms are related but thought it might be important to say that.Person was using this product due to osteoarthritis of the knees.Problem has not stopped since reduced or stopped use of the product.

• Brand Name: DUROLANE HYALURONIC ACID, STABILIZED SINGLE SHOT INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 14958351
• MDR Text Key: 295672154
• Report Number: MW5110765
• 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: 07/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: CURRENT PRESCRIPTION MEDICATIONS: DEXILANT.; CURRENT PRESCRIPTION MEDICATIONS: ESTRADIOL CREAM.; CURRENT PRESCRIPTION MEDICATIONS: LIPITOR.; CURRENT PRESCRIPTION MEDICATIONS: PROZAC.; CURRENT PRESCRIPTION MEDICATIONS: RETIN-A.; CURRENT PRESCRIPTION MEDICATIONS: VALTREX.; CURRENT PRESCRIPTION MEDICATIONS: XYZAL.; OVER-THE-COUNTER MEDICATIONS: ASPIRIN-BABY ONCE A DAY.; OVER-THE-COUNTER MEDICATIONS: B12.; OVER-THE-COUNTER MEDICATIONS: D3.; OVER-THE-COUNTER MEDICATIONS: FOLIC ACID.; OVER-THE-COUNTER MEDICATIONS: LUTIN.; OVER-THE-COUNTER MEDICATIONS: Q10.
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White