inforMED
InjuryMOZ

DUROLANE

Received Feb 26, 2020 · Event occurred Jan 1, 2020

Report MW5093310 · MDR key 9763544

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Lot number

89130-2020-1

Product problems

  • Improper or Incorrect Procedure or Method

Patient

76 YR

  • Unspecified Infection
  • Pain
  • Swelling
  • Unspecified Infection
  • Pain
  • Swelling

Narrative

Description of Event or Problem

PT CALLED TO REPORT AN ADVERSE EVENT INVOLVING HER DUROLANE INJECTION IN HER LEFT KNEE. PT STATED THAT WHEN SHE RECEIVED THE INJECTION 6 WEEKS AGO, THE PHYSICIAN, DR (B)(6), HIT THE BONE. THE PT SAID IT WAS VERY PAINFUL AND 2 WEEKS LATER HER LEFT KNEE BECAME VERY SWOLLEN AND INFECTED. THE PT SAID THE INFECTION WENT AWAY AFTER TWO WEEKS. THE PT STATED SHE WAS CHARGED (B)(6) FOR THE INJECTION, WHICH SHE FELT WAS AN OVERCHARGE. PT STATED SHE IS EXPERIENCING CONTINUING PAIN IN THE BACK OF HER LEG.