Limacorporate Discovery Elbow Mode D'emploi page 4

Some patients may be hypersensitive or allergic to the implant materials; this should be appropriately
considered by the Surgeon.
Follow the instructions of the manufacturer of bone cement (PMMA) for preparing the bone and applying the
bone cement for prosthesis fixation.
1.2. HANDLING AND STORAGE
All devices are provided sterile and should be stored at ambient temperature (indicative range 0-50° C / 32-
122° F) in their protective closed packaging in controlled rooms, protected from exposure to light, heat and
sudden changes in temperature.
Once the package is opened check that both the model and size of the implant correspond exactly to the
description printed on the labels. Avoid any contact between the implant and objects or substances that can
alter the sterile condition or the surface integrity. Careful visual examination of each implant is recommended
before use in order to verify that the implant is not damaged. Components removed from the package should
not be used if they are dropped or suffer other accidental impacts. Devices should not be modified in any way.
The device's code and lot number should be recorded in the patient's case history by using the labels included
in the components packaging.
The disposal of medical devices is to be performed by the hospitals in conformity with applicable laws.
Re-use of previously implanted devices must be absolutely avoided. Risks associated with reuse of single
use devices are: • infection; • early or late failure of the device or device fixation; • lack of appropriate coupling
between modular junctions (e.g. taper connections); • device wear and wear debris associated complications;
• transmission of diseases (e.g. HIV, hepatitis); • immune system response / rejection.
2. GENERAL INFORMATION ON INDICATIONS, CONTRAINDICATIONS AND RISK FACTORS
2.1. INDICATIONS
Discovery Elbow system is indicated for patients with: • Non-inflammatory degenerative joint disease including
osteoarthritis and avascular necrosis. • Rheumatoid arthritis. • Revision where other devices or treatments
have failed. • Correction of functional deformity. • Treatment of acute or chronic fractures with humeral
epicondyle involvement, which are unmanageable using other treatment methods.
All Discovery Elbow components are intended for use with bone cement.
2.2. CONTRAINDICATIONS
Absolute contraindications include: • infection, • sepsis, • osteomyelitis.
Relative contraindications include: • uncooperative patient or patient with neurologic disorders who is
incapable of following directions, • osteoporosis, • metabolic disorders which may impair bone formation,
• osteomalacia, • distant foci of infections which may spread to the implant site, • rapid joint destruction, marked
bone loss or bone resorption apparent on roentgenogram.
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