JRI VAIOS Mode D'emploi page 6

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
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. Inspect all devices
thoroughly prior to implantation and always ensure they are free from any damage, deformation, or
contamination.
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 guide wire is supplied sterile and is
intended for single use. DO NOT resterilise and/or reuse.
Implants MUST NOT be reused under any circumstances as the functionality, integrity and/or sterility of that
device may have been adversely affected and therefore cannot be guaranteed.
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 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 overtightened, 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
corresponding taper connections.
During the assessment of the range of motion, it is important to check the stability of the joint.
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 consider 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.
IFU 155-032 (Issue 13)
March 2023
VAIOS® Shoulder System
English
Page 6 of 146
® Shoulder System, with the