ChM STERILE VH202 Instrucciones De Utilizacion página 4

in the implant usage.
11) Any case where the implant components selected for use would be too
large or too small to achieve the successful result.
12) Any case that requires the simultaneous use of elements from different
systems that are made of different metals.
13) Any case in which implant utilization would disturb physiological pro-
cesses.
14) Blood supply limitation in the operative site.
15) Morbid obesity (defined according to the WHO standards).
16) Any case in which there is inadequate tissue coverage of the operative
site.
17) Inadequate bone quality for stable implant fixation (bone resorption,
osteopenia, and/or osteoporosis). This surgical treatment should not be
used in patients with a known hereditary or acquired osteogenesis im-
perfecta or calcification problems.
18) Pathologic changes of articular cartilage of humeral capitellum.
19) Patient in the phase of growth.
2. The above-mentioned list of contraindications is not exhaustive.
3 ADVERSE EFFECTS
1. The adverse effects may necessitate reoperation or revision. The surgeon
should warn the patient about the possibility of adverse effects occur-
rence.
2. The below-mentioned list of adverse events is not exhaustive. There is
a risk of occurrence of adverse events with unknown aetiology which may
be caused by many unpredictable factors.
3. Potential adverse events include but are not limited to:
1) Implant damage (fracture, deformation or detachment).
2) Early or late loosening, or displacement of the implant from the initial
place of insertion.
3) Possibility of corrosion as a result of contact with other materials.
4) Body reaction to implants as to foreign bodies e.g. possibility of tumour
metaplasia, autoimmune disease and/or scarring.
5) Compression on the surrounding tissues or organs.
6) Infection.
7) Bone fractures or "stress shielding" phenomenon causing loss of bone
above, below or at the operative site.
8) Haemorrhage and /or hematomas.
9) Pain.
10) Inability to perform everyday activities.
11) Mental condition changes.
12) Death.
13) Deep vein thrombosis, thrombophlebitis.
14) Occurrence of respiratory complications, e.g.: pulmonary embolism, at-
electasis, bronchitis, pneumonia, pulmonary infection, disturbed lung
growth, respiratory acidosis, etc.
15) Scar formation that could cause neurological impairment, or nerves
compression and /or pain.
16) Erosion of humeral head.
17) Damage to nerves.
18) Unintentional shortening or lengthening of the limb.
19) Elbow and/or forearm stiffness.
20) Wear and deformation of the articulating surfaces.
4 WARNINGS
1. The important medical information provided in this document should be
given to the patient.
2. The selection of proper shape and size of the implant appropriate
for a specific patient is crucial to achieve the success of the surgery.
The surgeon is responsible for this choice.
3. Preoperative and operating procedures, including knowledge of surgical
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