Limacorporate Discovery Elbow Mode D'emploi page 5

2.3. RISK FACTORS
The following risk factors may result in poor results with this prosthesis: • obesity
activities (active sports, heavy physical work); • incorrect implant positioning; • muscle deficiencies; • refusal
to modify postoperative physical activities; • patient history of infections; • systemic diseases and metabolic
disorders; • drug therapies that adversely affect bone quality, healing, or resistance to infection; • patient's
resistance to disease generally weakened (HIV, infections); • severe deformity leading to impaired anchorage
or improper positioning of implants; • use our combinations with products, prosthesis or instruments of another
manufacturer; • patient smoking.
3. WARNINGS
3.1. PRE-OPERATIVE PLANNING
LimaCorporate products should be implanted only by surgeons familiar with the joint replacement procedures
described in the specific surgical techniques. Pre-operative planning, through radiographic templates in
different formats, provides essential information regarding the type and size of components to be used and
the correct combination of devices required based on the anatomy and specific conditions of each patient.
Inadequate pre-operative planning can lead to improper selection of the implants and/or incorrect implant
positioning.
COMBINATIONS ALLOWED/NOT ALLOWED
X-small humeral components should only be used with x-small ulnar components.
X-small humeral condyles should only be used with x-small humeral components.
X-small bearing kits should only be used with x-small ulnar components.
LimaCorporate specialized technical staff is available to provide advice regarding pre-operative planning, the
surgical technique, and product and instrumentation assistance both prior to and during surgery.
The patient should be warned that the prosthesis does not replace normal healthy bone, that the prosthesis
can break or become damaged as a result of certain activity or trauma, that it has a finite expected implant life,
and may need to be replaced at some time in the future.
The possible impact of the factors mentioned in section 2 and 3.4. should be considered preoperatively and the
patient informed as to what steps he/she can take to reduce the possible effects of these factors.
Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability
and willingness of the patient to follow instructions, including control of weight and activity levels, 3) a good
1. According to the definition of the World Health Organization (WHO), Body Mass Index (BMI) greater than or equal to 30
; • strenuous physical
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