Important Safety Information

The Responsive Orthopedics Total Knee Arthroplasty System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint. The system includes femoral components, poly inserts, tibial trays and patella components available in cruciate retaining, ultra-conforming cruciate sacrificing, posterior stabilizing, and medial-pivot cruciate sacrificing versions. The implants are available in a variety of sizes to accommodate varying patient anatomy. The Responsive Orthopedics Total Knee Arthroplasty System implants are supplied sterile packed, and the instruments are supplied non-sterile.

INDICATIONS

The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• inflammatory degenerative joint disease including rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.

CONTRAINDICATIONS

Contraindications include but are not limited to:

1. Overt or suspected latent infection of the knee joint
2. Active infections at other sites that may spread to the knee join. Should a patient have any infection prior to implantation, the foci of that infection must be treated prior to, during, or after implantation
3. Patients with inadequate musculature or neuromuscular disorders leading to loss of function in the limb or possibly leading to complications in post-operative care
4. Patients with poor bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and fixation of the device
5. Severe ligamentous or muscle laxity, or inadequate soft tissue coverage to allow for normal healing and re-establishment of proper mechanics

POTENTIAL ADVERSE EVENTS

1. Osteolysis
2. Change in positioning, loosening, bending, cracking, fracture, deformation or wear of one or more of the components
3. Pain, dislocation, subluxation, decreased range of motion, or shortening or lengthening of the leg due to improper positioning, looseness, or wear of components
4. Femoral, tibial, or patellar bone fracture intraoperatively, or postoperatively due to trauma, excessive loading or poor bone stock
5. Allergic reactions to materials of components
6. Superficial or deep infection, which may delay healing and necessitate the removal of the prosthesis
7. On rare occasions, arthrodesis of the joint or amputation of the limb may be necessary
8. Nerve damage, deep vein thrombosis, periarticular calcification or ossification, articular injury, or vascular occlusion

WARNINGS

Never combine components with those made by different manufacturers.

Do not implant any device that has been used, or if the package appears damaged, tampered with or breached.

PRECAUTIONS

Surgeons should be familiar with the implant, instruments, and surgical technique before implanting this device.

Surgeons should consider the following factors which could lead to an increased rate of failure: excessive patient weight, high levels of patient activity, or poor bone stock.

The surgeon and O.R. staff should be careful not to damage or alter the components in any way, especially polished contact surfaces.

Instruments are provided non-sterile. The user facility must sterilize them before use.

Physician’s postoperative directions and warning to the patient and the corresponding patient compliance are extremely important. Detailed instructions on the use and limitations of the device should be given to the patient.

View full instructions for use