Synthes ACTIS DUOFIX, Instructions For Use Manual

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Postoperative
Strict adherence by the patient to the surgeon's instructions and warnings is extremely
important. Accepted practices should be followed in postoperative care.
The patient should be released from the hospital with complete written instructions and
warnings regarding exercises and therapies and any limitations on their activities. Partial weight
bearing with two crutches and later with one crutch should be continued until muscle function
is sufficiently restored so that the operated extremity is no longer overloaded if crutches are
discarded; this may take 10 to 12 weeks.
A continuing periodic patient follow-up is recommended. Because of the unknown functional
lifetime of the implant, particularly with respect to the maintenance of implant fixation and
UHMWPE bearing surfaces, A-P radiographs of the pelvis should be taken at each follow-up and
compared with previous radiographs and correlated with the clinical assessment of the patient.
If any radiographic changes are observed, such as the occurrence of radiolucencies, bone
resorption, or any changes in the position of an implant, these changes should be closely
monitored to determine whether they are static or progressive and the patient treated
appropriately.
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, often related to the factors listed in
WARNINGS AND PRECAUTIONS.
2. Early or late loosening of the prosthetic components, often related to factors listed in
WARNINGS AND PRECAUTIONS.
3. Fatigue fracture of the femoral stem, often related to factors listed in WARNINGS AND
PRECAUTIONS.
4. Excessive wear or fracture of the bearing components due to: intraoperative damage to the
prosthetic components, loose cement, bone fragments, metallic particles, ceramic particles or
other factors listed in WARNINGS AND PRECAUTIONS.
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, wear or particulate debris (such as loose cement, metallic, polyethylene or ceramic
particles)
Intraoperative
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. Breakage or chipping of the ceramic femoral head
8. Lengthening or shortening of the affected extremity.
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