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Contra-indications
The device should NOT be implanted where there is active infection, insufficient bone stock to support the
prosthesis or provide adequate fixation.
Contra-indications specific to VAIOS® Reverse:
Lack of functional deltoid
•
Contra-indications specific to VAIOS® Hemiarthroplasty:
Damaged glenoid articular cartilage
•
•
Irreparable rotator cuff
Further contra-indications may include the following conditions:
Severe muscle, nerve or vascular diseases that endanger the extremity in question
•
•
Severe deformations, tumours
•
Severe osteoporosis or deficient bone substance that may endanger stable seating of the prosthesis
Systemic and metabolic disorders
•
Weakened or compromised immune system (HIV, tumours, infections)
•
•
Absence of effective shoulder cuff or deltoid
Pregnancy and/or breastfeeding
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Precautions
The following conditions require caution and due consideration during pre-operative planning by the surgeon:
•
Obese or severely overweight patients
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Excessive loading through arduous activity
Lack of mental faculties to understand post-operative recuperative regime
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•
Alcohol dependency or drug abuse
•
History of falls or disabilities
Warnings
Implant components from one manufacturer MUST NOT be used together with those of another manufacturer,
since compatibility of mating parts cannot be assured except for product combinations specifically tested and
approved by JRI.
End Users
This device should only be implanted by operating surgeons who are familiar with the general problems of
prosthetic surgery and who are sufficiently trained to the product-specific operative technique. The surgeon is
responsible for ensuring the surgery is carried out properly and in line with the instructions provided in the
operative technique.
As a manufacturer, JRI Orthopaedics Ltd. is not responsible for any complications arising from incorrect diagnosis,
incorrect choice of implant, incorrect operative technique, treatment methods limitations or inadequate asepsis.
Pre-operative
Pre-operative planning allows the surgeon to assess for implant size and restoration of biomechanics. X-ray
templates should be used to estimate implant sizes, placement and joint alignment. Failure to carry out proper
planning may lead to incorrect choice of implant type/size.
Ensure all implant sizes and required instrumentation are available prior to surgery. Consult operative technique
and training materials provided by JRI Orthopaedics Ltd. before use.
Functionality of surgical instruments should be checked. Use of damaged instruments may lead to early failure of
implant. Considerations of anatomic loading, soft tissue condition and component placement are critical to
minimise a variety of postoperative complications.
IFU 155-032 (Issue 13)
March 2023
VAIOS® Shoulder System
English
Page 5 of 146
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