| SURGICAL
PROCEDURES – SHOULDER SYSTEM |
Indications
for Use
DESCRIPTION
The
Buechel-Pappas™ Integrated Shoulder Replacement system,
in providing the surgeon with maximum options for shoulder
reconstruction, consists of the following components: a humeral
stem, available in a broad range of sizes for optimum fixation
and fit; humeral heads, available in 3 diameters, which attach
to the stem with a taper fit, locked in place by an interference-fit
screw; a glenoid component, consisting of a polymer bearing
insert backed by a metal shell, available in 3 sizes with
fixation screws;
STERILIZATION
All
titanium 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. If package is damaged, contents should not be used
and Endotec, Inc. should be contacted.
INDICATIONS
The
Buechel-Pappas™ Integrated Shoulder Replacement System
is intended for reconstruction of painful and/or severely
disabled shoulder joints resulting from osteoarthritis, rheumatoid
arthritis, traumatic arthritis, avascular necrosis, or previously
failed prostheses. For proper function of the Humeral Head
Resurfacing Component, the humeral head must be of sufficient
bone stock to support the loads on it. Also, the presence
of an intact or reconstructable rotator cuff is important
for proper functioning and dislocation resistance.
CONTRAINDICATIONS
- Any
active or suspected latent infection in or about the shoulder
joint.
- Mental
or neuromuscular disorders which would create an unacceptable
risk of prostheses instability, prostheses fixation failure,
or complications in postoperative care.
- Insufficient
or dysfunctional rotator cuff (except for the Modular Salvage
Shoulder).
Other
contraindications for use as a total shoulder replacement
include pathological conditions of the gleno-humeral joint
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 glenoid.
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 procedures.
POROUS
COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.
WARNINGS
Where
there is loss of, or insufficient 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 life 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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