inforMED
MalfunctionISH

K2 SENSATION C4 S27 R

Received Mar 31, 2015 · Event occurred Dec 30, 2014

Report 3003764610-2015-00006 · MDR key 4658761

Device

Generic name

Component, External, Limb, Ankle/foot

Manufacturer

Ossur

Model number

K2P0427R

Catalog number

K2P0427R

Product problems

  • Detachment Of Device Component

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

FINAL EVALUATION OF PRODUCT COMPLETED (B)(6) 2015.

Description of Event or Problem

PROSTHETIC PATIENT WALKING UPSTAIRS WHEN THE PROSTHETIC FOOT CAME OFF. PT STARTED TO FALL BUT WAS CAUGHT PRIOR TO FALLING.