The VerSys Epoch FullCoat Hip System is the first reduced-stiffness stem specifically designed to address all patient femoral anatomies to minimize implant-related complications such as thigh pain, stress shielding, and leg lengthening discrepancies.1,2 The innovative flexible composite stem closely mimics the bending stiffness of bone.
It is 75% less stiff than cobalt-chromium (CoCr) alloy stems and 50% less stiff than titanium alloy stems to address thigh pain and reduce the risk of stress shielding.3 Its extensively porous coating provides both initial and long-term implant stability.4
The VerSys Epoch Fullcoat Hip Prosthesis is provided sterile by prior exposure to gamma irradiation indicated by the symbol on the labeling and remain sterile as long as the package integrity has not been violated. Inspect each package prior to use and do not use the component if any seal or cavity is damaged or breached or if the expiration date has been exceeded. Once opened, the component must be used or discarded.
These sterilization instructions are consistent with ANSI/AAMI/ISO standards and guidelines. They should only be used for sterile items that were opened-but-unused.
Do not reuse devices labeled for single use only.
Do not resterilize:
Composite femoral stems (sizes 13-22) by any method.
Single-use only components that have been contaminated with body fluids or debris or previously implanted.
Any components that are past the labeled expiration date.
The system is indicated for:
The VerSys Epoch FullCoat Hip is indicated for patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion and patients with acute femoral neck fractures.
It is not recommended that insertion be done where there has been extensive infection involving the bone; or when involved soft tissue cannot be removed; or where the organism is gram negative, antibiotic resistant Staphylococcus aureus; or where highly virulent or mixed organisms are involved.
1800 West Center Street
Warsaw, Indiana 46580 USA