| SURGICAL
PROCEDURES – HIP SYSTEM |
Indications
for Use
SYSTEM
COMPONENTS
The Buechel-Pappas™ Integrated Hip Replacement System,
in providing the surgeon with maximum options for hip reconstruction,
consists of the following components; A femoral resurfacing
component for a conservative approach on younger patients,
available in a broad range of sizes for optimum fixation and
fit; femoral stems in standard lengths and modular using distal
tip extensions for maximum canal stability and optimum proximal
fill; femoral heads, available in a range of neck lengths
and diameters, which attach to the stem with a taper fit;
several types of acetabular components consisting of a metal
backed or an all poly design in a range of outside and inside
diameters; a self-aligning (bi-polar) component consisting
of a polymer bearing insert backed by an outer metal shell
in a range of diameters.
The Buechel-Pappas™
Integrated Hip Replacement System utilizes: UltraCoat®
TiN coating applied by a PVD process with a coating thickness
of 5-10 microns and a hardness (Hv) of 2500-2800. UltraCoat
improves corrosion resistance, biocompatibility, and reduces
UHMWPe wear of Ti-6Al-4V. Biocoat® a sintered commercially
pure titanium (CPTi) porous bead coating with a mean pore
size of 350 ?m and a porosity of 35%.
STERILIZATION
All titanium and cobalt chromium implant components are provided
sterilized by exposure to a minimum of 25 Kilograys of gamma
radiation. All UHMWPe components are provided sterilized by
exposure to ethylene oxide. Self-Aligning components metal
shell and plastic bearing are packaged together and sterilized
by exposure to ethylene oxide. If package is damaged, contents
should not be used and Endotec Inc. should be contacted.
INDICATIONS
The Buechel-Pappas™ Integrated Hip Replacement System
is intended for reconstruction of painful and/or severely
disabled hip joints resulting from osteoarthritis, rheumatoid
arthritis, traumatic arthritis, avascular necrosis, or previously
failed prosthesis.
CONTRAINDICATIONS
- Any
active or suspected latent infection in or about the hip
joint.
- Mental
or neuromuscular disorders which would create an unacceptable
risk of prostheses instability, prostheses fixation failure,
or complications in postoperative care. Other contraindications
for use as a total hip replacement include pathological
conditions of the acetabulum which would prevent achieving
proper range of motion, appropriate head stability, and/or
a well-seated and supported smooth articulation of the head
within the acetabulum.
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. Sizing between components
should only be performed as indicated in the surgical procedure.
WARNINGS
Where there is loss of, or insufficient acetabular bone stock,
bone grafting or other adjunctive reinforcement procedures
are advisable to provide socket-support and cup containment.
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.
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
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