Use Instructions

Page |
26
6. LIMITATIONS
The patient needs to have sufficient intramedullary space to accommodate the increased length
of the CTE implant in order to avoid cortical perforation. Before choosing the CTE implant for a
patient, assess if the patient’s anatomy is appropriate by using the Canary CTE implant X-Ray
Templates.
The patient must have access to a computer with USB connection and home wireless Internet
access in order for their data to be collected, stored, and transmitted by the CTE with CHIRP
System.
7. CONTRAINDICATIONS
The Canary Tibial Extension (CTE) is contraindicated for use in patients who are undergoing
procedures or treatments at or in the proximity of the CTE using ionizing radiation, as these could
damage the CTE.
After a patient receives TKA surgery with the Canary CTE with CHIRP System and Zimmer
Biomet Persona® Personalized Knee System, make the patient aware that electrical currents
conducted or induced into the body from an external source are contraindicated for patients with
an active implantable medical device.
Before performing TKA on any patient, consider the following contraindications.
The Zimmer Biomet Persona® Personalized Knee System is contraindicated for use in patients
who have:
Previous history of infection in the affected joint and/or other local/systemic infection
that may affect the prosthetic joint
Insufficient bone stock on femoral or tibial surfaces
Skeletal immaturity
Neuropathic arthropathy
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the
affected limb
A stable, painless arthrodesis in a satisfactory functional position
Severe instability secondary to the absence of collateral ligament integrity
Total Knee Arthroplasty is contraindicated in patients who have rheumatoid arthritis (RA)
accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin because their
risk of postoperative infection is greater. RA patients using steroids may also have increased risk
of infection. Late infections in RA patients have been reported 24+ months postoperative.
Physician Instructions for Use
DRAFT