Limacorporate Discovery Elbow Mode D'emploi page 8

of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight. • Fretting and crevice
corrosion can occur at interfaces between components. • Wear and/or deformation of articulating surfaces.
• Intraoperative or postoperative bone fracture and/or postoperative pain. • Bearing and/or condyle components
may disassociate causing the elbow to disarticulate. • Revision and post-traumatic patients are susceptible to
higher wear rates if varus/valgus constraints are compromised.
4. STERILITY
a. Implants
All implantable components of the Discovery Elbow system are provided sterile with a Sterility Assurance
Level (SAL) of 10 . All components are sterilized by radiation. Do not use any component from a package
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that has been previously opened or appears to be damaged. Do not use implants after the expiration date
printed on the label.
b. Instruments
Instruments are supplied non sterile and must be cleaned, disinfected and sterilized before use according
to appropriate validated methods (refer to the "Instrument Care, Cleaning, Disinfections and Sterilization"
brochure for validated sterilization parameters; this brochure is available on request or downloadable from
www.limacorporate.com in the Products section). Users should validate their specific cleaning, disinfection
and sterilization processes and equipments.
5. MAGNETIC RESONANCE IMAGING (MRI)
Discovery Elbow System components have not been evaluated for safety and compatibility in the MR
environment. The devices have not been tested for heating or migration in the MR environment. The risks
associated with a passive implant in an MR environment have been evaluated for other prosthetic systems and
are known to include heating, migration and image artifacts at or near the implant site.
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