MalfunctionISY
GENIUM X3
Received Jul 1, 2026 · Event occurred Aug 28, 2025
Report 9615892-2026-00015 · MDR key 25674754
Device
Generic name
External Knee Prosthetic Component
Manufacturer
Otto Bock Healthcare Products GmbhModel number
3B5-3Catalog number
3B5-3
Product problems
- Unintended System Motion
Patient
NA · Male
- Abrasion
- Bruise/Contusion
- Fall
Narrative
Description of Event or Problem
CLIENT REPORTS RANDOM LACK OF RESISTANCE WHEN WALKING. NO BEEPS OR ERROR MESSAGES. HIS KNEE WAS GOING INTO FREE SWING, AND STAYING IN SWING UNTIL CONNECTION TO CHARGER. HAPPENED ONCE WHILE WALKING, HE FELL. HAPPENED SEVERAL OTHER TIMES WITHOUT FALL. FALL ON CONTRA KNEE. BRUISE + ??. FUNCTION HAS RETURNED. CLIENT FELL AT SCHOOL, WHILE WALKING ,WHEN IT WENT INTO FREE SWING. HAPPENED OTHER TIMES WITH STUMBLE. FELL ONTO SOUND KNEE. BRUISED AND BROKEN SKIN.