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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Weight: 124