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

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Loss of Range of Motion (2032); Numbness (2415); Ambulation Difficulties (2544); Balance Problems (4401); Paresthesia (4421)

Event Date 07/21/2021

Event Type  Injury  

Event Description

Had bilateral injections of 3ml in each knee of durolane. Made by bioventus. My feet went numb i could not stand without assistance. Injection given on (b)(6) 2021. Waited the 24 - 48 hours because i have had euflexxa injection previously so i was familiar with routine. As days passed no improvement on the sensation of numbness, i could not stand without assistance, i could not lift my legs up to lift my self onto my bed, i could not stand prone i would tilt forward or backwards, i would walk and it felt like they were not working with the rest of my body. Called the orthopedic dr who administered and he prescribed a steroid pack. Took the steroids and after a week i still had numbness, tingling, no coordination, it felt like muscle loss in my legs. I went to hospital on (b)(6) 2021 they had an attending orthopedic dr come in who answered the on call for my dr office and stated it was a severe reaction attacking my muscles and had no idea on what to administer to see if they could counter act the effect of the injection. A stronger steroid and antispasmodic drug was given and it did not help at all. I made appointment to see my orthopedic dr and all he had to say was his part was durolane injection given, and he couldn't understand why i still could not walk without assistance. As of today i still need assistance to get dressed, bathe, sit, stand, and i am currently using a cane to try to keep my balance and do not know why i had a reaction to this particular injection. Fda safety report id # (b)(4).

• Brand Name: DUROLANE INJECITON
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 12313255
• MDR Text Key: 266410416
• Report Number: MW5103192
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 08/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/11/2021 Patient Sequence Number: 1