Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA

Exclusion Criteria

• •All subjects:
• •Subject has conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately-sized implant, e.g.:
• •* blood supply limitations;
• •* insufficient quantity or quality of bone support, e.g., osteoporosis, metabolic disorders which may impair bone formation, radioactive bone disease, tumor around hip joint, and osteomalacia;
• •* infections or other conditions which may lead to increased bone resorption.
• •Subject has dysplasia of hip joint with CROWE Grade III, IV.
• •Subject has bodily disease(s) that may interfere with THA survival or outcome.
• •Subject has life expectancy of less than 10 years.
• •Subject has mental or neurological conditions which impair the subject's ability or willingness to restrict activities that may put the affected limb at risk.
• •Subject has physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities.
• •Subject has neuromuscular dysfunctions (paralysis, myolysis and abductor muscle weakness) which will cause unstable hip joint or abnormal gait after surgery.
• •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
• •Subject has an active infection - systemic or at the site of intended surgery.
• •Subject has a Body Mass Index \> 40.0 kg/m².
• •Subject has a known allergy to any component of the devices used in the study.
• •Subject is pregnant or breast feeding.
• •Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation.
• •Revision Subjects:
• •Subject has inadequate implant support with an increased risk of implant failure if support is not achieved, poor bone quality exists, or smaller sized implants are utilized.
• •Subject needs revision of a fractured ceramic head or liner.
• •Subject was already enrolled into this study as primary THA case.