Persona IQ^®

Indications

The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient’s total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery.

The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58 mm sized tibial stem extension.

The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.

The CTE with CHIRP System is compatible with Zimmer Persona^® Personalized Knee System.

Contraindications

The canturio™ te (CTE) is contraindicated for use in patients who are undergoing procedures or treatments at or in the proximity of the CTE using therapeutic ionizing radiation can result in shortened battery life or premature failure of electronic components. Damage to the CTE by therapeutic ionizing radiation may not be immediately detectable.

Before performing TKA on any patient, consider the following contraindications.

The Zimmer Biomet Persona^® 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.