Contraindications - Limacorporate SMART SPACE 3D Mode D'emploi

2.2. CONTRAINDICATIONS

Contraindications include: • Use with devices other than LimaCorporate shoulder implants; • Use with joint
other than shoulder; • Use with non-adult patient populations; • Use with patients with conditions that would
affect bony landmarks identification, shoulder joint fractures, or patients with conditions or disease that affect
bony landmarks recognition; • Use for revision cases, so patients with a prosthesis already in place; • Use in
case of active infection of the surgical area where the surgery will be performed; • Use with patients allergic to
the material used for Smart SPACE 3D Positioners System manufacturing; • Use in case of verified anatomical
difference between the pre-operative and the intraoperative condition; • Use in case of insufficiently stable
bone; • Use in case of known presence of implants that can cause artifacts on the CT-scan.
2.3. RISK FACTORS
The following risk factors may result in poor results with this device: • Incorrect use of the Smart SPACE
Shoulder Planner can lead to inadequate design and/or manufacturing of Smart SPACE 3D Positioners
System (for details about the possible risk factors related to the use of the planner, please refer to the Smart
SPACE Shoulder Planner Instructions For Use); • Surgeon altering the size of the 3D Positioner and/or the
bony anatomy before placing the 3D Positioner. Debris from the alteration could contaminate the operating
area. In addition, altering the size of the 3D Positioner lead to mismatch between the 3D Positioner and the
patient anatomy; • Apply excessive loads on the 3D Positioner during surgery; • Significant change of patient's
anatomy since the time of the CT-scan; • Inaccurate placement of the 3D Positioner during surgery; • Use of
short K-wire during surgery (K-wire guide shall be 200 mm ±2 mm in length and 2.5 mm ±0.04 mm in diameter
to prevent inaccurate placement of K-wire); • Soft tissue interference can lead to a non-correct seating of
the 3D Positioner; • Use with products, prosthesis or instruments of another manufacturer, unless otherwise
specified in the Case Report; • Other risk factors can be found in the SMR Shoulder System and the SMR
TT Hybrid Glenoid System Instructions For Use. Those risk factors are specifically related to the possibility to
obtain poor results with the above-mentioned implants, which are implanted by means of the Smart SPACE
3D Positioners System.
3. WARNINGS
3.1. PRE-OPERATIVE PLANNING
LimaCorporate products should be used only by surgeons familiar with the joint replacement procedures
described in the specific device surgical techniques (Case Report). Pre-operative planning provides essential
information regarding the type and size of components to be used and the correct combination of devices
required, based on the anatomy and specific conditions of each patient. Inadequate pre-operative planning
can lead to: • improper selection of the implants; • incorrect design of the 3D Positioner(s); • incorrect 3D
Positioner(s) and/or implant positioning.
Smart SPACE 3D Positioners System must not be used with components/instruments of other manufacturers.
The manufacturer and the dealer are not liable for possible coupling incompatibility. The surgeon is solely
responsible for the choice and use of the devices.
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