Patient Risk Information
Biomet Knee Joint Replacement Prostheses

INDICATIONS
You may be a candidate for total knee replacement if your doctor indicates you have any of the following conditions:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity level, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.

CONTRAINDICATION
You are not a candidate for total knee replacement if you have any of the following conditions: infection, sepsis, and osteomyelitis. You may not be a candidate for total knee replacement if your doctor indicates that any of the following affect the potential for a positive outcome: 1) uncooperative patient or patient with neurologic disorders who is incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, 7) vascular insufficiency, muscular atrophy, neuromuscular disease, 8) incomplete or deficient soft tissue surrounding the knee.

WARNINGS
Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.

Malalignment or soft tissue imbalance can place inordinate forces on the components which may cause excessive wear to the patellar or tibial bearing articulating surfaces. Revision surgery may be required to prevent component failure.

Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. While these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.

Accepted practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitations of the reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. Excessive activity, trauma and excessive weight have been implicated with premature failure of the implant by loosening, fracture, and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone making successful revision surgery more difficult. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits.

1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis or osteolysis may be a result of loosening of the implant.
2. Early or late postoperative infection and allergic reaction.
3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.
4. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.
5. Periarticular calcification or ossification, with or without impediment of joint mobility.
6. Inadequate range of motion due to improper selection or positioning of components.
7. Undesirable shortening of limb.
8. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions.
9. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.
10. Fretting and crevice corrosion can occur at interfaces between components.
11. Wear and/or deformation of articulating surfaces.
12. Valgus-varus deformity.
13. Transient peroneal palsy secondary to surgical manipulation and increased joint movement has been reported following knee arthroplasty in patients with severe flexion and valgus deformity.
14. Patellar tendon rupture and ligamentous laxity.
15. Interoperative or postoperative bone fracture and/or postoperative pain.