Limacorporate SMR Gebrauchsanweisung Seite 11

• stem subsidence; • instability of the system because of inadequate soft tissue balancing; • dissociation due
to incorrect coupling of the devices; • infection; • local hypersensitivity; • local pain; • periprosthetic fractures,
including intraoperative fractures; • bone resorption; • temporary or permanent nerve damage; • fretting of
modular junctions; • excessive wear of UHMWPE components due to damaged articular surfaces or the
presence of particles; • metallosis; • heterotopic ossification; • scapular notching; • rotator cuff failure; • glenoid
erosion (only in hemi procedures); • loss of range of motion; • additional surgery.
Some adverse effects can lead to death. General complications include venous thrombosis with/without
pulmonary embolism, cardiovascular or pulmonary disturbances, haematomas, systemic allergic reactions,
systemic pain, blood loss, donor site morbidity, temporary or permanent paralysis.
4. STERILITY
a. Implants
All implantable components of the SMR Shoulder System are provided sterile with a Sterility Assurance Level
(SAL) of 10 . Metal components are sterilized by EtO or radiation (E-beam or Gamma rays) while UHMWPE
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components are sterilized by EtO. HA coated implants are sterilized only by radiation (E-beam or Gamma rays).
Do not use any component from a package 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 equipment.
5. MAGNETIC RESONANCE IMAGING (MRI)
The SMR System has 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 and are known to include heating, migration and image
artifacts at or near the implant side.
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