CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Indications
Total joint replacement is indicated for patients
suffering from disability due to:
• degenerative, post-traumatic or rheumatoid
arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration,
particularly when there is patellofemoral
erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion
deformities.
This device may also be indicated in the salvage of previously failed surgical attempts.
While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Contraindications
Total joint replacement is contraindicated
where there is:
• infection (or a history of infection), acute or
chronic, local or systemic;
• insufficient bone quality which may affect
the stability of the implant;
• muscular, neurological or vascular
deficiencies, which compromise the
affected extremity;
• obesity;
• alcoholism or other addictions;
• materials sensitivity;
• loss of ligamentous structures;
• high levels of physical activity (e.g.
competitive sports, heavy physical labor).
Precautions and Warnings
An implant should never be reused. Although the implant may appear undamaged, previous stresses could create imperfections that may lead to mechanical failure. It is advised to utilize new prostheses of current design.
Familiarity with, and attention to the surgical technique recommended for this device is imperative for best results. The correct selection as well as the correct seating/ placement of the prosthetic implant is extremely important. Only Encore® Knee System instruments and trial prostheses should be used.
Care must be taken to protect mating surfaces (i.e. tapers) and polished bearing surfaces from nicks and scratches which could become the focal point for failure. Contouring or bending of the implant may reduce its service life and may cause immediate or eventual failure under load. An implant must not be tampered with, as tampering will adversely affect the performance of the implant.
Preoperative Planning and Postoperative Care
Preoperative planning provides essential information regarding the appropriate prosthesis and likely combinations of components. Use instrument trial components for fit verification (where applicable) and extra implant components for backup. X-ray templates for all sizes of the Encore Knee systems are available upon request.
Accepted surgical practices should be followed for postoperative care. The patient should be made aware of the limitation of total joint reconstruction. Excessive physical activity and trauma affecting the replaced joint have been implicated in premature failure by loosening, fracture, and/or wear of the prosthetic implants. The patient should be cautioned to govern his activities accordingly as the risk of implant failure increases with weight and activity levels of the patient.
Adverse Effects
Some of the adverse effects that could occur related to total knee arthroplasty are:
• fracture of the tibia or femur;
• transient peroneal palsy secondary to surgical manipulation;
• patellar subluxation or dislocation;
• patellofemoral impingement;
• instability, changes in position , or loosening of components;
• ligamentous laxity;
• dissociation of components;
• infection;
• poor range of motion;
• shortening of limbs;
• metal sensitivity reactions.