inforMED
InjuryISH

ICELOCK 651 SMOOTH

Received Jun 7, 2024 · Event occurred May 21, 2024

Report 3003764610-2024-00004 · MDR key 19481965

Device

Generic name

Prosthetic Lock

Manufacturer

Ossur Hf

Model number

L-651000

Lot number

HF230601

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

NA · Unknown

  • Limb Fracture
  • Limb Fracture

Narrative

Description of Event or Problem

PATIENT ATTEMPTED WALKING AFTER DONNING THE PROSTHESIS AND STEPPED OUT OF THE DEVICE WHICH RESULTED IN A FALL AND A HUMERAL-NECK FRACTURE.

Additional Manufacturer Narrative

NO PRODUCT FAILURE WAS IDENTIFIED. USER FAILED TO ENGAGE THE PIN IN THE LOCK BEFORE WALKING WITH THE PROSTHESIS.

Description of Event or Problem

PATIENT ATTEMPTED WALKING AFTER DONNING THE PROSTHESIS AND STEPPED OUT OF THE DEVICE WHICH RESULTED IN A FALL AND A HUMERAL-NECK FRACTURE.