Use Instructions

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The CTE with CHIRP System is designed to operate autonomously. Using its proprietary data

collection and power management algorithms, the CTE implant will collect, store, and transmit

encrypted raw kinematic data from the implant’s triaxial accelerometers and triaxial gyroscopes

via the patient’s home Base Station unit to the Cloud. The data will then be processed, analyzed,

and converted to quantifiable Canary Medical Gait Parameter metrics.

After post-operative day 3, the patient can log on to the previously-established Canary account

to view the Patient Dashboard. The patient can use an Internet browser to view the Patient

Dashboard by following the instructions in the Patient IFU. Gait parameters presented on the

Patient Dashboard are for the previous sample day’s activity.

12. ADVERSE EVENTS

Potential adverse events associated with TKA and/or the Zimmer Biomet Persona® Personalized

Knee System with the CTE with CHIRP System include but are not limited to those listed below:

Knee-joint infection

Heart attack

Stroke

Blood clots

Bleeding

Slow wound healing

Infection

Allergic reaction to the knee implant components

Blood vessel damage

Nerve damage

Stiffness

Poor range of motion

Swelling and joint pain

Knee instability and/or dislocation

Loosening or fracture of the knee implant components

Bone fracture or break during surgery

Leg length discrepancy

13. COMPATIBILITY WITH OTHER DEVICES

The CTE implant is designed to interface with the Tibia Plate of the Zimmer Biomet Persona®

Personalized Knee System. The surgical team attaches the CTE to the Zimmer device to form the

patient’s knee prosthesis. Specialized Canary Medical instrumentation is used during the

attachment process and tibia preparation.

Physician Instructions for Use

DRAFT