Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study

Inclusion criteria

To be included in Group 1, subjects must meet all of the following criteria:

• Has been implanted with appropriate components of the WMT MOM THA System
• Has previously undergone primary THA for any of the following:

• non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• inflammatory degenerative joint disease including rheumatoid arthritis;
• correction of functional deformity.
• Is willing and able to complete required study visit(s) and assessments
• Plans to be available for the required study visit
• Is capable of providing sufficient blood for sampling according to blood draw procedures
• Is willing to sign the approved Informed Consent document

Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4) the subject agrees to a second Informed Consent document and data collection specific to the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted in this study.

To be included in Group 2, subjects must meet all of the following criteria:

• Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants
• Is not an employee of the Investigator
• Is willing and able to provide Informed Consent document
• Is willing and able to attend the requested study visit(s) and assessments
• Is capable of providing sufficient blood for sampling according to blood draw procedures

Exclusion criteria

Subjects will be excluded from either study group if they meet any of the following criteria:

• Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Subject is unwilling or unable to sign the Informed Consent document
• Subject has documented substance abuse issues
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Subject is currently incarcerated or has impending incarceration
• Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator)
• Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation