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U.S. Department of Health and Human Services

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

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BIOVENTUS LLC DUROLANE INJECTION ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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).
 
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Brand NameDUROLANE INJECTION
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key12313255
MDR Text Key266410416
Report NumberMW5103192
Device Sequence Number2
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
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 Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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
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