JRI
VAIOS
®
Shoulder System
•
Difficult clinical management problems where other methods of treatment may not be suitable or may be
inadequate
Contra-indications
The device should NOT be implanted where there is active infection, insufficient bonestock to support the
prosthesis or provide adequate fixation.
VAIOS® Anatomic
and
VAIOS® Humeral Resurfacing
are contraindicated where there is not an intact or
reconstructable 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
•
Systematic and metabolic disorders
•
Weakened or compromised immune system (HIV, tumours, infections)
•
Absence of effective shoulder cuff or deltoid
Warning
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.
Precautions
The following conditions require caution and due consideration during pre-operative planning by the surgeon:
•
Obese or severely overweight patients
•
Excessive loading through arduous activity
•
Lack of mental faculties to understand post-operative recuperative regime
•
Alcohol dependency or drug abuse
•
History of falls or disabilities
In patients’ with a high body mass index, where delayed surgery is feasible, it is advisable that a programme of
weight reduction is undertaken prior to any joint replacement surgery.
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.
Transient bacteraemia can occur after surgical procedures. To prevent late infection at the implant site, many
orthopaedic surgeons advise the use of antibiotic prophylaxis before and after such procedures for their patients.
Intra-operative
IFU 155-032_Iss.9
June 2019
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