inforMED
InjuryMOZ

GELYSN-3

Received Jul 17, 2025 · Event occurred May 6, 2025

Report 22529948 · MDR key 22529948

Device

Generic name

Acid, Hyaluronic, Intraarticular

Manufacturer

Bioventus Llc

Lot number

C16533

Product problems

  • Patient-Device Incompatibility

Patient

70 YR · Female

  • Pneumonia
  • Sepsis
  • Vomiting
  • Dizziness
  • Convulsion/Seizure
  • Unspecified Respiratory Problem
  • Pneumonia
  • Sepsis
  • Vomiting
  • Dizziness
  • Convulsion/Seizure
  • Unspecified Respiratory Problem

Narrative

Description of Event or Problem

PATIENT RECEIVED GELYSN-3 (HYALURONIC ACID) 16.8 MG/2ML INJECTION BILATERALLY INTO HER KNEES ON [DATE REDACTED] AROUND 1340. PT HAS NO HISTORY OF SEIZURES. AT 1548 THE PT WAS THEN TAKEN TO OUTSIDE HOSPITAL¿S EMERGENCY DEPARTMENT LATER FOR DIZZINESS, VOMITING, AND SEIZURE-LIKE ACTIVITY. PT WAS ADMITTED FOR ASPIRATIONAL PNA [PNEUMONIA] AND ACUTE METABOLIC ENCEPHALOPATHY. PT WAS ADMITTED TO THE HOSPITAL FOR 8 DAYS AND TREATED TO THE ABOVE IN ADDITION TO ACUTE HYPOXEMIC RESPIRATORY FAILURE AND SEPSIS. PT¿S FAMILY INFORMED [REDACTED] ORTHOPEDIC OFFICE ON [DATE REDACTED] -- APPROXIMATELY TWO MONTHS AFTER INJECTION, THAT THE OUTSIDE HOSPITAL HAD PHARMACEUTICAL FORENSICS THAT TESTED THE REMAINED OF THE GELYSN INJECTIONS THAT THE FAMILY POSSESSED AFTER THE FIRST INJECTION WAS ADMINISTERED. PER THE FAMILY, THE TESTING SHOWED A HIGHER DOSE OF HYALURONIC ACID IN THE GEL INJECTIONS THAN THERE IS SUPPOSED TO BE. PER THE FAMILY, THE OUTSIDE HOSPITAL ALSO CONFIRMED THAT THE INJECTION WAS DONE CORRECTLY. SINCE DISCHARGE THE PT HAS HOME PHYSICAL THERAPY AND IS RECOMMENDED TO BILATERAL KNEE OFF-LOADERS.