inforMED
InjuryMOZ

DUROLANE INJECITON

Received Aug 11, 2021 · Event occurred Jul 21, 2021

Report MW5103192 · MDR key 12313255

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Product problems

  • Device Appears to Trigger Rejection

Patient

51 YR

  • Loss of Range of Motion
  • Numbness
  • Ambulation or Postural Difficulties
  • Balance Problems
  • Paresthesia
  • Loss of Range of Motion
  • Numbness
  • Ambulation or Postural Difficulties
  • Balance Problems
  • Paresthesia

Narrative

Description of Event or Problem

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).