MalfunctionIQI

PROCARE 20" UNIV BASIC KNEE SPLINT

Received Jan 8, 2026 · Event occurred Dec 4, 2025

Report 24003605 · MDR key 24003605

Device

Generic name

Orthosis, Limb Brace

Manufacturer

Djo Llc

Catalog number

79-96019

Lot number

TJ04103250825

Patient

NA · Unknown

Abrasion
Unspecified Infection

Narrative

Description of Event or Problem

PATIENT WHO HAS BEEN THROUGH SEVERAL SURGERIES FOR AN INFECTED TOTAL KNEE REPLACEMENT SHOWED STAFF THAT THE METAL BARS IN THE BACK OF HIS KNEE IMMOBILIZER WERE NOT COMPLETELY ENCLOSED IN THE BRACE. THEY WERE STARTING TO CAUSE ABRASIONS ON THE BACK OF HIS LEG WHICH COULD INCREASE RISK OF FURTHER INFECTION DUE TO OPEN SKIN.