JRI
VAIOS
®
Shoulder System
•
Aseptic loosening of implant
•
Dislocation, subluxation, insufficient range of movement
•
Damage to soft tissue, cuff insufficiency, instability, stiffness
•
Fracture of implant, periprosthetic bone or cement
•
Allergy/hypersensitivity reactions
•
Cardiovascular/pulmonary embolism, respiratory infection, venous thrombosis, neuronal dysfunction,
haematoma or delayed wound healing
Revision
In cases of revision, a total anatomic shoulder prosthesis can be revised to a total reverse shoulder prosthesis.
Longer humeral stem are also available for revision purposes. Ensure that all fragments of the primary prosthesis
and any bone cement (if applicable) are removed, the area cleansed and prepared in accordance with the operative
technique instructions.
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.
UHMWPE cannot be re-sterilised.
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.
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
• Maximum spatial field gradient of 720 gauss/cm
• Maximum whole body averaged specific absorption rate (SAR) of 3.0W/kg
Under the scan conditions defined above, the
VAIOS Shoulder System
is expected to produce a maximum
temperature rise of 1.7°C after 15 minutes of continuous scanning.
The image quality may be compromised if the area of interest is in the exact same area, or relatively close to, the
position of the medical device. Therefore, optimization of MR imaging parameters to compensate for the presence
of this device may be necessary:
Pulse Sequence
T1-SE
T1-SE
GRE
GRE
Signal Void Size
42,763-mm
2
17,875-mm
2
56,249-mm
2
28,917-mm
2
Plane Orientation
Parallel
Perpendicular
Parallel
Perpendicular
Additional information regarding MRI safety is available upon request at JRI Orthopaedics Ltd.
IFU 155-032_Iss.9
June 2019
Page 7 of 85
