Indications for Use

DESCRIPTION
Buechel-Pappas (B-P) Total Knee Replacement System is intended to provide primary or revision options to the surgeon to reduce or eliminate pain, restore motion, and/or correct deformity. A cementless, porous coated surface, BioCoat®, with a mean pore size of 350 microns and a porosity of 35% is available on all metallic implants in addition to non-porous coated cemented devices.

The Buechel-Pappas Tricompartmental Knee Replacement system consists of the following components; a Titanium-Nitride coated, Titanium alloy femoral and tibial, and an UHMWPe bearing insert, and metal backed patellar components made of titanium alloy, with an UHMWPe bearing. All polyethylene patellar and tibial components are also available.

STERILIZATION
All metallic implant components are provided pre-sterilized by exposure to a minimum of 25 Kilograys of gamma radiation. All UHMWPe components are provided pre-sterilized by exposure to ethylene oxide. (Note: The patellar component contains both plastic and metal, and is sterilized by ETO due to the poly, even though metallic components are present)

INDICATIONS
Prerequisite Selection Criteria

Indications

Contraindications

PRECAUTIONS
Before clinical use, the surgeon should be familiar with all aspects of the surgical procedure. Patients should be instructed in the limitations of the prosthesis and should be taught to govern their activities accordingly.

WARNINGS
Improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent reduction in the service of the prosthetic implants.

Accepted practices should be followed meticulously in postoperative care and the patient should be made aware of the limitations of total joint reconstruction. Heavy labor, active sports, or other disorders of the hip or knee could increase loading of the ankle and decrease its function.

As in any surgical procedure, there are risks involved in total joint replacement in general. Complications that may develop include: early or late infection that may require that the device be removed and the joint fused, blood vessels and nerves may be damaged, bones may be fractured during the procedure, the device may loosen or break, allergic reactions to the metallic components may occur, phlebitis may develop and cause possible lung problems, long term swelling may occur, and there may be delayed wound healing. Some complications may cause prolonged illness, a draining wound, a need for blood transfusions, a need for further major surgery, and/or permanent pain, deformity, and inconvenience. Very rarely some complications may be fatal. Several additional risks are also present due to anesthesia and general surgery itself. These include, heart damage, brain damage, paralysis either from anesthesia (i.e. epidural) or neurological damage, tissue necrosis from tourniquet, chance of HIV or other diseases from blood transfusions, and permanent disability. These possible complications are not unique to the B-P Knee Replacement, but may occur with any total joint replacement operation. Additionally, as with any joint prosthesis, there are postoperative activity limitations that the subject must accept. These activity limitations are often individual in nature, depending on the subject’s age, general health, preoperative condition of the knee, condition of other joints, and preoperative activity level.

Risks that can be imposed on patients due directly to the device itself are:

BIOCOAT® is a registered trademark of Endotec, Inc.
ULTRACOAT® is a registered trademark of Endotec, Inc.
BUECHEL-PAPPAS is a trademark of B-P Trust