Limacorporate SMR Gebrauchsanweisung Seite 10

3.2. INTRAOPERATIVE
The use of trial devices is recommended to check the correct site preparation, size and positioning of the
implants to be used. It is recommended that additional implants be available during surgery for use in those
cases requiring prostheses of different sizes or when the preoperatively selected prostheses cannot be used.
The correct selection as well as the correct seating/placement of the implant is extremely important. Improper
selection, positioning, alignment and fixation of the implant components may result in unusual stress conditions
which may negatively affect system performance and survival rate of the implant. The components forming
original LimaCorporate systems must be assembled according to the surgical technique and used only for the
labelled indications. Use only instruments and trial components specifically designed for use with the implants
being used. The use of instruments from other manufacturers or the use of instruments designed for use with
other systems can lead to inappropriate preparation of the implant site, incorrect positioning, alignment and
fixation of the devices followed by loosening of the system, loss of functionality, reduction of the durability of the
implant, and the need for further surgery. Care must be taken to protect the surfaces involved in the coupling
between components (tapers); articular surfaces of the implants should be protected from scratches or any
other damage. All component coupling surfaces should be clean and dry before assembly. The stability of
component couplings should be verified as described in the surgical technique.
3.3. POST-OPERATIVE CARE
Adequate post-operative care should be provided by the surgeon or other suitably qualified medical staff.
Regular postoperative x-ray follow up is recommended to detect any changes in position of the implant or
surrounding tissues.
The surgeon should make the patient aware of the limitations of limb function after shoulder arthroplasty and
that the reconstructed joint must be protected from full load bearing for a period of time. Excessive physical
activity or trauma to the replaced shoulder joint can lead to premature failure of the shoulder arthroplasty
through loosening, fracture, or abnormal wear of the prosthetic implants. The patient should be cautioned by
the surgeon to govern activities accordingly and advised that the implants may fail due to excessive joint wear.
In particular the following precautions should be presented to the patient by the surgeon: • avoid repeated
high weight lifting; • keep body weight under control; • avoid sudden peak loads (consequences of activities
such as contact sports, playing tennis) or movements which can lead to sudden stops or twisting; • avoid
positions that can increase the risk of dislocation, such as for example excessive degrees of abduction and/
or internal rotation.
Lack of appropriate post-operative rehabilitation instructions and care can negatively influence the outcome of
the surgical procedure. Care must be taken when handling Trabecular Titanium devices; they should not get in
contact with fabrics that can release particles inside the trabecular structure.
3.4. POSSIBLE ADVERSE EFFECTS
Adverse effects can occur in shoulder arthroplasty include: • loosening of the prosthetic components, for
example due to osteolysis; • prosthesis dislocation and instability; • breakage or damage of the device;
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