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LCS® Complete™ – P.F.C.® Sigma™ RP Mobile-bearing Total Knee System

IMPORTANT

This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

INDICATIONS

CEMENTED USE:The LCS® Complete™ – P.F.C.® Sigma™ RP Mobile Bearing Total Knee System is indicated for cemented use in cases of osteoarthritis and rheumatoid arthritis. The RP-F insert and femoral component are indicated where a higher than normal degree of postoperative flexion is required. The rotating platform prosthesis and modular revision components are indicated for revision of failed knee prostheses.

UNCEMENTED USE:The porous coated Keeled and Non Keeled M.B.T.™ (Mobile Bearing Tibial) Tray configurations of the LCS Total Knee System are indicated for noncemented use in skeletally mature individuals undergoing primary surgery for reconstructing knees damaged as a result of noninflammatory degenerative joint disease (NIDJD) or either of its composite diagnoses of osteoarthritis and post-traumatic arthritis pathologies. The Rotating Platform device configuration is indicated for use in knees whose anterior and posterior cruciate ligaments are absent or are in such condition as to justify their sacrifice. The P.F.C. Sigma RP Curved bearings when used with the P.F.C. Sigma Cruciate Retaining Femoral Component can be used in posterior cruciate ligament retaining procedures.

CONTRAINDICATIONS

The use of the LCS Complete – P.F.C. Sigma RP Mobile Bearing Total Knee System is contraindicated in:

• the presence of osteomyelitis, pyrogenic infection or other overt infection of the knee joint;

• patients with any active infection at sites such as the genitourinary tract, pulmonary system, skin or any other site. Should a patient have any infection prior to implantation, the foci of the infection must be treated prior to, during and after implantation.

• patients with loss of musculature or neuromuscular compromise leading to loss of function in the involved limb or in whom the requirements for its use would affect recommended rehabilitation procedures.

• patients with severe osteoporosis or other metabolic bone diseases of the knee.

• patients with any of the following conditions:

- lesions of the supporting bone structures (e.g. aneurysmal or simple bone cysts, giant cell tumor or any malignant tumor),

- systemic and metabolic disorders leading to progressive deterioration of solid bone support,

- the presence of severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity, fixed deformities greater than 60° of flexion, 45° of genu varus or valgus,

- known drug or alcohol addiction,

- skeletally immature individuals and the presence of allergic reaction to implant metals or polyethylene are also contraindications for the noncemented, porous coated, M.B.T. and LCS Complete – P.F.C. Sigma RP Mobile Bearing device configurations, and for the cemented use of all device configurations of the LCS Complete – P.F.C. Sigma RP Mobile Bearing Total Knee System.

CONTRAINDICATIONS FOR USE WITHOUT CEMENT

Noncemented use of the Porous Coated Keeled or Non-Keeled M.B.T. Tray device configurations is contraindicated in patients with sufficient loss in quantity or quality of bone stock (as determined on x-ray) such that successful noncemented fixation is unlikely. Additional contraindications may become apparent at the time of surgery. These include:

• vascular deficiency at the bone site;

• inadequate bone stock to assure both a firm press fit and close apposition of the cut bone surfaces to the prosthesis;

• the inability to make bone cuts so as to assure both correct component position and intimate apposition of bone and prosthetic surfaces;

• inadequate bone quality (e.g. severe osteoporosis) and lack of stability of the implanted components.

In the presence of any of the above conditions the components should be fixed with cement.

WARNINGS AND PRECAUTIONS

Components labeled for “Cemented Use Only” are to be implanted only with bone cement. The following conditions tend to adversely affect knee replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints.

ADVERSE EVENTS

The following are the most frequent adverse events after knee arthroplasty: change in position of the components, loosening, bending, cracking, fracture, deformation or wear of one or more of the components, infection, tissue reaction to implant materials or wear debris; pain, dislocation, subluxation, flexion contracture, decreased range of motion, lengthening or shortening of leg caused by improper positioning, looseness or wear of components; fractures of the femur or tibia.

References

1. souchen,dun.“RotatingPlatformTotalKneeProstesesReduceAxialRotational Constraint Torque.” 2011

2. engh,gerard,A.etal.“RevisionTotalKneeArthroplasty.”,williamsandwilkins,co.1997.

3. Jones,R.g.“mobilebearingsinRevisionTotalKneeArthroplasty.”AAOsInstructionalcourselectures,vol.54,2005.

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©DePuy Orthopaedics, Inc. 2012.Allrightsreserved.

0612-00-506 (Rev. 4) 2M 0312

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