ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population

Within primary TKA, there are factors that lead to more complex procedures that include
patients with high BMIs, advanced preoperative deformities and ligamentous laxity. Such cases
may require the surgeon to treat using ancillary components, such as stems and/or augments
and/or additional constraint.

This post-market study will evaluate the short/medium term clinical performance and medium
term survivorship of the ATTUNE Revision system system, which includes instrumentation, in
complex primary TKA. The study is designed as a worldwide non-comparative, multi-center study
with each site initially having a cohort of approximately 20 Subjects to recruit. The study
will enroll 200 fixed bearing and 200 rotating platform configurations.

The 2-year KOOS-ADL (activities of daily living) was selected as the primary endpoint because
it will evaluate the post-operative period during which outcomes typically plateau and will
therefore provide a good indication of longer term outcomes

Male and female Subjects, age 22-80 years, inclusive, who require a primary knee arthroplasty
in a joint that, due to deformity, instability, bone loss etc., necessitates the use of
implants found within the ATTUNE Revision knee system and are suitable candidates for TKA
using the ATTUNE® Revision system are eligible for enrollment in this study.

Inclusion Criteria:

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

2. The decision to have knee replacement with the study device is regardless of the
research.

3. The devices are to be used according to the approved indications.

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. Subject, in the opinion of the Investigator, is able to understand this clinical
investigation and is willing and able to perform all study procedures and follow-up
visits and co-operate with investigational procedures.

7. 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.

8. Subject has not been diagnosed with an inflammatory arthritis (including gout,
rheumatoid, psoriatic etc.)

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. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral
joint replacement) or primary TKA in affected knee.

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

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

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

8. 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.

9. 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.

10. 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).

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

12. Subject has been diagnosed with an inflammatory arthritis (including uncontrolled
gout, rheumatoid, psoriatic etc.).