JRI VAIOS®Shoulder System
Always use a trial for any test fit and to check the range of motion. No responsibility can be taken for complications
due to improper implantation technique or non-specific instrumentation. Failure to use the optimum size of implant
ensuring sufficient fixation may result in early revision surgery.
It is important to have adequate and continuous bone support of the H-A.C. components, particularly the glenoid.
When preparing the bed for the glenoid component, use care to preserve a portion of the subchondral bone plate.
Glenoid preparation is initiated using a short guide wire manufactured from non-implant grade stainless steel and
that provides a positional and angular reference for a cannulated reamer. The guidewire is supplied sterile and is
intended for single use. DO NOT resterilise and/or reuse.
All modular junctions must be firmly impacted together to prevent dissociation. Taper joints should be clean and
dry prior to impaction. Repeated assembly and disassembly of modular components could compromise the locking
action of the taper joint. Wherever possible, modular junctions should be assembled prior to implantation.
It is essential that the components are assembled to the correct technique as specified in the operational technique
and that any connection bolts are tightened to the correct torque values. It is also essential that the locking caps
on the glenoid screws are securely tightened to the correct torque and that care is taken during placement. Care
should also be taken when fitting the UHMWPE inserts into the metal glenoid backing or the reverse cup. These
components CANNOT be reused.
Adjunctive proximal fixation/support is required for 220mm long stems. Where there is loss of proximal bone stock,
or poor proximal bone quality, bone grafting or other adjunctive proximal fixation/support is advised for implant
stability. It is important that the prosthesis is not distally fixed without proximal support.
Care should be taken not to overtighten bone screws. Ensure the appropriate selection of bone screw length and
location to avoid damage to underlying soft tissue areas. When using the reverse anatomy configuration, ensure
that the retaining screw is not cross-threaded or over tightened, and is fully located within the axial recess of the
corresponding reverse anatomy dome. If the screw cannot be fully located in the recess, or fails to engage in the
glenoid, the location of the dome should be checked before attempting to reapply the screw.
Components should only be used with other compatible components of the VAIOS®Shoulder System, with the
corresponding taper connections. 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.
During the assessment of the range of motion, it is important to check the stability of the joint. For the anatomic
total shoulder, insufficient tension in the rotator cuff mechanism can lead to subluxation of the humeral component
increasing the risk of glenoid loosening and lead to higher wear rates due to edge loading.
Post-operative
Physicians should ensure patients are aware of implant loading limitations and ensure consistent post-operative
care, from a suitably qualified professional, is made available. The incidence and severity of complications are
usually greater in surgical revisions than primary operations. Early detection of an impending complication allows
for timely and effective countermeasures.
Post-operative care should incorporate recognised procedures and take into account information from the
operative technique and documented according to internal hospital procedures. Failure to do this may result in
malalignment, delayed wound/bone healing, implant failure, infection or impaired joint function
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.)
•Infection
IFU 155-032_Iss.9
June 2019
