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Side Effects
As with all major surgical procedures, side effects and adverse events can occur. Some of the more common
complications include:
Problems resulting from anaesthesia and patient positioning (pain, nausea etc.)
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Problems resulting from use of bone cement (i.e. Bone Cement Implantation Syndrome)
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Infection
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Aseptic loosening of implant
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Glenoid erosion (specific to VAIOS® Hemiarthroplasty)
Scapular notching (specific to VAIOS® Reverse)
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Dislocation, subluxation, insufficient range of movement
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Damage to soft tissue, cuff insufficiency, instability, stiffness
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Fracture of implant, cement or periprosthetic bone
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Allergy/hypersensitivity reactions
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Cardiovascular/pulmonary embolism, respiratory infection, venous thrombosis, neural dysfunction,
haematoma or delayed wound healing
Storage & Handling
VAIOS Shoulder System prostheses including guidewires are supplied sterile having been sterilised by Gamma
irradiation. Discard single use guidewires after use. DO NOT resterilise.
Implants manufactured from UHMWPE CANNOT be resterilised.
Store implants in their original protective packaging in a clean and dry atmosphere.
Do not use if the packaging is damaged.
Do not use this product after the expiry date (year-month) shown on the product packaging.
Avoid removing from packaging until immediately prior to use. Inspect device prior to use. Visibly damaged,
scratched, improperly handled implants and implants that have already been used must not be implanted under
any circumstances as the functionality, integrity and/or sterility of that device may have been adversely affected
and therefore cannot be guaranteed. Exposed articular surfaces must be neither marked nor come into contact
with metallic or hard objects. Touching the articular surfaces, the Hydroxyapatite coating or the tapered interface
for the liner must be avoided.
A red colour strip being present on the righthand side of the product label that is attached to both the sterile
barrier and the carton indicates that the device has been through the gamma irradiation cycle. Do not use the
device if this colour strip is orange, as this may indicate the device has not been through the gamma irradiation
cycle and therefore may be non-sterile.
The product should not be exposed to sunlight.
Any disposal of the device, its accessories and the consumables used with it should follow hospital waste
processing procedures.
MRI Safety Information
Non-clinical testing has demonstrated that VAIOS® Shoulder System is MRI Conditional. A patient with this device
can be safely scanned in an MR system meeting the following conditions:
Static magnetic field of 3.0 T
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Maximum spatial field gradient of 720 gauss/cm
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Maximum whole body averaged specific absorption rate (SAR) of 3.0W/kg
IFU 155-032 (Issue 13)
March 2023
VAIOS® Shoulder System
English
Page 7 of 146
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