ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites
that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study
devices. The follow-up period of 5 years was selected to cover both the early post-operative
period as well as the medium term period which is a good indicator of longer term
survivorship.

The primary endpoint of survivorship at 5 years was selected to capture the time period
during which the majority of revision failures occur while providing a good indication of
long term survivorship. The secondary outcomes include commonly used measures of clinical
performance that will allow for comparison with published literature. Additionally, patient
reported outcomes, AORI bone defect classification , satisfaction and pain scores will be
collected and analyzed.

Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee
arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable
candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in
this study. The use of the ATTUNE Revision system includes both partial and complete revision
surgical procedures, including implantation of revision components as the second stage within
a two-stage treatment for infection.

Inclusion Criteria

1. Subject is male or female and between the ages of 22 and 80 years at the time of
consent, inclusive.

2. Subject presents with a primary knee arthroplasty (primary TKA, unicompartmental) or
prior revision TKA that requires a revision procedure of implanted tibial and/or
femoral components.

3. The decision to perform a knee revision with the study device is regardless of the
research.

4. Subject that is willing to give voluntary, written informed consent to participate in
this clinical investigation and authorize the transfer of his/her information to the
Sponsor

5. Subject is currently not bedridden

6. The devices are to be used according to the approved indications.Subject is able to
read, and comprehend the Informed Consent Document as well as complete the required
PROMs in either English or one of the available translations.

Exclusion Criteria:

1. The Subject is a woman who is pregnant or lactating.

2. Contralateral knee has already been enrolled in this study.

3. Subject had a contralateral amputation.

4. Subject is currently diagnosed with radicular pain from the spine that radiates into
the limb to receive RTKA.

5. Subject has participated in a clinical investigation with an investigational product
(drug or device) in the last three (3) months.

6. Subject is currently involved in any personal injury litigation, medical-legal or
worker's compensation claims.

7. Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last
5 years) or has a psychological disorder that could affect his/her ability to complete
patient reported questionnaires or be compliant with follow-up requirements.

8. Subject was diagnosed and is taking prescription medications to treat a muscular
disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or
polymyalgia.

9. Subject has a significant neurological or musculoskeletal disorder(s) or disease that
may adversely affect gait or weight bearing activities (e.g., muscular dystrophy,
multiple sclerosis, Charcot disease).

10. Subject has a medical condition with less than five (5) years life expectancy as
determined by the Investigator.

11. Uncontrolled gout