Contraindications - Mathys seleXys DS Gebrauchsanweisung

English
Instructions for using the seleXys ® DS
For the surgeon carrying out the operation
1. Choice of the device
This package contains a hip prosthesis intended for replacing a natural hip joint. The surgeon is responsible for only
combining cup components made by the same manufacturer and in accordance with the surgical technique, failing which
the manufacturer cannot accept any liability. Before planning combinations with components belonging to other implant
systems, it is advisable to check the compatibility of the conical connecting piece, of the acetabular articulation or of the
spherical-head assembly system. Any combination with endoprosthesis systems from a different manufacturer requires the
prior written consent of the manufacturer. Cup implants are available in a range of progressive sizes. Templates enable the
appropriate size to be chosen during the pre-operative planning stage. The surgeon should ensure that there will be no
interferences or incompatibilities between the components of the hip prosthesis and any other implanted devices (in terms
of dimensions or materials). A head originating from a primary implant must not be reimplanted. Ceramic heads must be
mounted solely on cones that have never been used before. Any intra-operative replacement of a head must be carried out
solely with a metal head, providing the cone has not deteriorated in any way as a consequence of the extraction of the
previous head. In the framework of a revision, in order to ensure the durability of the system it is recommended to replace
the polyethylene part of the cup, even if it does not appear to be worn. The decision to anchor the seleXys DS Revision
cup in place (cortical screw and fixing pins) must be reached by the surgeon with proper consideration for the patient's
bone quality. N.B.: do not subject the tab to repeated or alternated bending as this could weaken it! This device must be
implanted with the help of the appropriate seleXys DS instrument set.
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2. Compatibility of materials
The following head-insert combinations are not permitted:
• alumina ceramic / zirconia ceramic • ceramic materials supplied by different manufacturers.
The manufacturer cannot accept any liability in the event of failure to comply with these conditions.
3. Indications
• Diseases of the hip joint resulting from degenerative processes of post-traumatic or inflammatory origin • Fracture or
avascular necrosis of the femoral head • Chronic joint instability • After-effects of earlier operations, total hip prosthesis,
osteotomy etc.

4. Contraindications

• Acute or chronic local or systemic infections • Severe muscular, neurological or vascular deficiencies affecting the limb
concerned • Bone destruction or poor bone quality liable to affect the stability of the implant • Any concomitant diseases
liable to affect the function of the implant • Direct contact of local, acid antibiotics with hydroxyapatite ceramic-coated
implants • Allergies to the implant components
5. Factors liable to prejudice the success of the operation
• Severe osteoporosis • Significant deformations, congenital dislocation • Local bone tumours • Ligament instability or
serious untreatable muscle spasms • Metabolic diseases • Drug addiction • Alcoholism • Obesity • Accidents, falls •
Intense physical activity or repetitive movements which subject the device to excessive loads (competitive sports, running,
physical work etc...)
6. Possible side effects
The following are considered the most typical and frequent undesired effects of hip arthroplasty:
• dislocation • infection • vein thrombosis and pulmonary embolism • cardiovascular problems • haematoma • loosening
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