DUROLANE
Received Dec 6, 2021 · Event occurred Nov 12, 2021
Report MW5105859 · MDR key 12953574
Device
Generic name
Acid, Hyaluronic, Intraarticular
Manufacturer
Bioventus Llc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR · Male
- Pain
- Inadequate Pain Relief
- Ambulation or Postural Difficulties
- Pain
- Inadequate Pain Relief
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
I HAD A DUROLANE (BIOVENTUS) INJECTION FOR KNEE PAIN ON (B)(6) 2021. THAT DAY, I REPORTED TO MD OFFICE THAT IT FELT LIKE A BAD BRUISE ON THE LOWER INSIDE OF MY RIGHT KNEE. THE LEFT KNEE (ALSO INJECTED) FELT FINE. I UNDERSTOOD THERE MIGHT BE TRANSIENT PAIN AFTER INJECTION, AND IT MIGHT TAKE A FEW WEEKS FOR PRE-INJECTION DISCOMFORT TO HOPEFULLY LESSEN, BUT IT'S 3 WEEKS LATER AND MY KNEE HAS GOTTEN PROGRESSIVELY WORSE. MY QUALITY OF LIFE IS MUCH WORSE THAN BEFORE THE INJECTION. MY ABILITY TO WALK IS VERY HAMPERED WITH CONSTANT LIMPING. I CANNOT GET THROUGH THE NIGHT. CERTAINLY, I HAD THE KNEE TREATED BECAUSE THERE WERE ISSUES BEFORE, BUT IT IS NOW MUCH WORSE THAN IT WAS WITH CONSTANT PAIN ON THE INNER JOINT. I HAVE RESTED, ICED, TAKEN OTC NSAIDS. ALL TEMPORARILY HELPED SYMPTOMS, BUT, AGAIN, IT'S WORSE DAY BY DAY. FDA SAFETY REPORT ID# (B)(4).