inforMED
MalfunctionISY

Genium X3

Received Jul 29, 2026 · Event occurred Dec 9, 2024

Report 9615892-2026-00016 · MDR key 50067411

Device

Generic name

External Knee Prosthetic Component

Model number

3B5-3

Catalog number

3B5-3

Product problems

  • Unintended System Motion

Patient

Male

  • Fall
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

Incorrect joint behavior - one-time absence of stance phase resistance: The user fell while walking because the joint suddenly no longer provided any resistance.The joint unexpectedly switched off despite showing 3 battery bars and without any audible warning signal. The patient fell three times. When weight-bearing, the joint felt unstable and "spongy."ON (b)(6)2025: The customer provided the following feedback:The issue was a sudden loss of resistance (without any warning signals).After briefly connecting the charging cable, the joint functioned normally for a few minutes, but then suddenly became freely movable again without warning.