Depuy Synthes Delta Xtend Bedienungsanleitung Seite 5

The Delta Xtend Reverse Shoulder Prosthesis has not been evaluated for safety and
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compatibility in the MR environment. The Delta Xtend Reverse Shoulder Prosthesis has
not been tested for heating or migration in the MR environment.
CAUTION: The following conditions, singularly or concurrently, tend to impose severe loading
on the affected extremity, thereby placing the patient at higher risk of failure of the shoulder
arthroplasty:
1. Obesity or excessive patient weight.
2. Manual labor.
3. Active sports participation.
4. High levels of patient activity.
5. Likelihood of falls.
6. Alcohol or drug addiction.
7. Other disabilities, as appropriate.
The following conditions singularly or concurrently, tend to adversely affect the fixation of the
shoulder replacement implants:
1. Marked osteoporosis or poor bone stock.
2. Metabolic disorders or systemic pharmacological treatments leading to progressive
deterioration of solid bone support for the implant (e.g., diabetes mellitus, steroid therapies,
immunosuppressive therapies, etc.).
3. History of general or local infections.
4. Severe deformities leading to impaired fixation or improper positioning of the implant.
5. Tumors of the supporting bone structures.
6. Allergic reactions to implant materials (e.g., bone cement, metal, polyethylene).
7. Tissue reactions to implant corrosion or implant wear debris.
8. Disabilities of other joints.
WHEN THE SURGEON DETERMINES THAT TOTAL SHOULDER OR HEMI-SHOULDER REPLACEMENT IS
THE BEST MEDICAL OPTION AVAILABLE AND DECIDES TO USE THIS PROSTHESIS IN A PATIENT WHO
HAS ANY OF THE ABOVE CONDITIONS OR WHO IS SIMPLY YOUNG AND ACTIVE, IT IS IMPERATIVE
THAT THE PATIENT BE INSTRUCTED ABOUT THE STRENGTH
LIMITATIONS OF THE MATERIALS USED IN THE DEVICE AND FOR FIXATION AND THE RESULTANT
NEED TO SUBSTANTIALLY REDUCE OR ELIMINATE ANY OF THE ABOVE CONDITIONS.
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 patient's failure
to adhere to the surgeon's orders may delay postoperative recovery and/or increase the risk of
adverse effects including implant or implant fixation failure. The functional life expectancy of
prosthetic shoulders is, at present, not clearly established.
INFORMATION FOR USE
Preoperative
The surgeon should discuss all physical and mental limitations particular to the patient and all aspects
of the surgery and products with the patient before surgery. The discussion should include limitations
of the procedure and the mechanical limitations of the material(s) selected for implantation. Factors
that could impose limits on the performance and stability of the implant(s) e.g., activity level and
patient weight should be described to the patient so as to maximize the potential for long-term
freedom from complications. The necessity of following the surgeon's instructions regarding these
factors following the operation must be clearly understood by the patient.
An adequate inventory of sterile implant sizes should be on hand at the time of surgery.
Surgical Technique
For most implants, written instructions are available to ensure that the surgeon is conversant
with the operating procedure. Further information on surgical techniques and DePuy products is
available on request. Careful pre operative planning on the basis of radiographic findings should
be carried out routinely. Radiographic templates are available for this DePuy shoulder.
lntraoperative
Proper handling of implants is mandatory. These prostheses should only be handled by personnel
wearing sterile surgical gloves. Prior to surgical use, a visual inspection of each implant 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. The head protective cover should be left on
until the prosthesis is used. Increasing the anteversion of the glenoid component in total shoulder
replacement may result in instability and/or dislocation.
Prior to closure, the surgical site should be thoroughly cleansed of bone chips, extraneous
cement, ectopic bone, etc. Ectopic bone and/or bone spurs may lead to dislocation or painful and
restricted motion.
Handling
Extreme care must be taken while handling the implant so that it is not scratched or damaged
in any way. Implants should be stored in their unopened packaging. Where protective covers are
provided they should be left in place until immediately prior to use.
HA Coated Implants
HA coated implants must not be implanted with cement.
Modular Implants
Under no circumstances should a DePuy modular implant component be combined with another
component of a different manufacturer. Care must be taken to ensure the components to be
assembled are mutually compatible and that they are impacted together with the appropriate
instruments. It is essential that male and female connector sections be examined to ensure they
are completely clean prior to assembly.
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