DePuy Synthes ATTUNE Instrucciones De Empleo página 6

The surgical and postoperative management of the patient must be carried out with due
consideration for all existing conditions. Mental attitudes or disorders resulting in a
failure to adhere to the
the risk of adverse effects including implant or implant fixation failure.
Excessive physical activity or trauma to the replaced joint may contribute to premature failure
of the knee replacement by causing a change in position, fracture, and/or wear of the
implants. The functional life expectancy of prosthetic knee implants is, at present, not
clearly established. The patient should be informed that factors such as weight and activity
levels may significantly affect wear.
MRI SAFETY INFORMATION
The ATTUNE Fixed Bearing Knee System has 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 artifacts at or near the implant site.
INFORMATION FOR USE
Preoperative
The surgeon should discuss all physical and mental limitations particular to the patient and all
aspects of the surgery and the prostheses with the patient before surgery. The discussion
should include the limitations and possible consequences of joint replacement, and the
necessity to follow the surgeon's instructions postoperatively, particularly in regard to patient
activity and weight.
Surgeons should not begin the clinical use of any knee prosthesis before they have
thoroughly familiarized themselves with its specific implantation technique. Certain methods
may change with time as further clinical experience is gained. Such changes are presented at
regularly scheduled surgical instruction courses for which periodic attendance is advised.
Surgical technique brochures and recordings are available from DePuy.
Specific prerequisites for total knee replacement that must be strictly followed include:
1. Significant arthritic disease of the tibio-femoral and/or patello-femoral surfaces.
2. Stable or reconstructable collateral ligaments. The ATTUNE CR component design allows
for the retained posterior cruciate ligament and/or balanced posterior capsule to assist in
appropriate rollback of the femur.
3. Physiologic or correctable axial alignment.
4. Intact quadriceps and hamstring mechanisms.
5. If a patella component is to be used, the patella bone must be suitable for accepting the
patella component.
lntraoperative
It is recommended that extra implants be available at the time of surgery, including sizes
larger and smaller than those expected to be used.
Proper handling of implants is mandatory. These prostheses should only be handled by
personnel wearing sterile surgical gloves. Do not allow contact of any component with hard
objects. Prior to use, a visual inspection of each implant component for possible
imperfections should be routinely performed. Damage or alterations to any implant
component may produce stresses and/or cause defects which could become the focal point
for implant failure.
surgeon's orders may delay postoperative recovery and/or increase
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patient's