inforMED
InjuryLOF

PHYSIOSTIM

Received Feb 2, 2026 · Event occurred Oct 17, 2025

Report MW5183088 · MDR key 24229066

Device

Generic name

Stimulator, Bone Growth, Non-invasive

Manufacturer

Orthofix Us Llc.

Model number

655315-0001

Patient

86 YR · Female

  • Cyst(s)
  • Pain
  • Impaired Healing
  • Ambulation or Postural Difficulties
  • Easy Bruising

Narrative

Description of Event or Problem

REPORTER'S SURGEON RECOMMENDED THIS STIMULATOR DEVICE DUE TO HER HIP BONE NOT HEALING AS QUICKLY AS WANTED. SHE USED THIS DEVICE FOR 3 DAYS, 3 HOURS PER DAY. REPORTER STATES BEING IN A WORSE CONDITION THAN WHEN SHE STARTED USING THE DEVICE. SHE HAD MORE PAIN, HAD TO START GOING TO PHYSICAL THERAPY, AND STARTED USING A CANE. REPORTER STATES HER PAIN BEING UNBEARABLE AND THE SURGEON TELLING HER TO DISCONTINUE USING THE DEVICE. SHE ALSO STATES THAT THE DEVICE BURST A CYST ON HER BACK AND LEFT HER HEAVILY BRUISED. REPORTER STATES FINDING ONLINE THAT THE MANUFACTURER HAS SEVERAL CLASS ACTION LAWSUITS AGAINST THEM.