| SURGICAL
PROCEDURES – TMJ SYSTEM |
| Surgical
Procedures Information: |
| TMJ
SP |
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Indications
for use
DESCRIPTION
The
Hoffman-Pappas Temporomandibular Joint Replacement consists
of the following components; a Titanium-Nitride coated Titanium
alloy ramus and a metal backed UHMWPe bearing fossa component
both of which are secured to the bone with screws.
STERILIZATION
All
titanium implant components are provided pre-sterilized by
exposure to a minimum of 25 Kilograys of gamma radiation or
ethylene oxide. All UHMWPe components are provided pre-sterilized
by exposure to ethylene oxide.
INDICATIONS
The
Hoffman-Pappas Temporomandibular Joint is intended for reconstruction
of painful and/or severely disabled TMJ 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 TMJ
joint.
- Mental
or neuromuscular disorders which would create an unacceptable
risk of prostheses instability, prostheses fixation failure,
or complications in postoperative care.
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.
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