Depuy Synthes Corail AMT Bedienungsanleitung Seite 9

of an implant, these changes should be closely monitored to determine whether they are static or
progressive and the patient treated appropriately.
MRI SAFETY INFORMATION
Corail AMT HA coated stems have not been tested for safety and compatibility in the MR environment.
The devices have not been tested for heating or migration in the MR environment. Scanning a patient
who has this device may result in patient injury.
The risks associated with other passive implants in an MR environment have been evaluated and are
known to include heating, migration, and image artefacts at or near the implant site.
ADVERSE EVENTS AND COMPLICATIONS
The following are generally the most frequently encountered adverse events and complications in
hip arthroplasty:
General
1. Change in position of the prosthetic components.
2. Early or late loosening of the prosthetic components.
3. Fatigue fracture of the femoral stem.
4. Wear or fracture of the polyethylene component.
5. Early or late infection.
6. Peripheral neuropathies. Subclinical nerve damage may also occur as a result of surgical trauma.
7. Tissue reactions, osteolysis, and/or implant loosening caused by metallic corrosion, allergic
reactions, or the accumulation of polyethylene or metal wear debris or loose cement particles.
lntraoperative
1. Acetabular perforation.
2. Femoral shaft perforation, fissure, or fracture, which may require the use of internal fixation.
3. Trochanteric fracture.
4. Damage to blood vessels (e.g. iliac, obturator and femoral artery).
5. Temporary or permanent nerve damage (e.g. femoral, obturator or isolated peroneal nerve).
6. Subluxation or dislocation of the hip joint due to implant size or configuration selection,
positioning of components and/or muscle and fibrous tissue laxity.
7. Lengthening or shortening of the affected extremity.
Early Postoperative
1. Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial
infarction.
2. Hematoma and/or delayed wound healing.
3. Pneumonia and/or atelectasis.
4. Subluxation or dislocation.
Late Postoperative
1. Trochanteric avulsion from excessive muscular tension, weight-bearing, or inadvertent
intraoperative weakening of the trochanter.
2. Aggravation of problems in the ipsilateral or contralateral knee and ankle joints due to leg length
discrepancy, femoral medialization and/or muscular deficiencies.
3. Femoral or acetabular fracture due to trauma or excessive loading, particularly in the presence of
poor bone stock caused by severe osteoporosis, bone defects from previous surgery, intraoperative
reaming procedures, or bone resorption.
4. Bone resorption, which may contribute to the deterioration of fixation and eventual loosening of
the implant.
5. Periarticular calcification or ossification, which may lead to a decrease in joint mobility and range
of motion.
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