This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: NexGen® LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees
PMA Applicant: Zimmer, Inc.
Address: P.O. Box 708, 1800 West Center Street, Warsaw, Indiana 46581
Approval Date: December 10, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060037a.pdf
What is it? The NexGen ® LPS-Flex Mobile Bearing Knee and LPS-Mobile Bearing Knee are artificial mobile bearing knee systems that are designed to replace the knee joint. The systems have three parts:
- A metal curve-shaped part (femoral component), which a doctor cements onto the end of the thigh bone;
- A flat metal ‘tray’ that is cemented onto the top of the shin bone (tibia); and
- A plastic support (bearing) that sits on the tibial tray and mates with the curved femoral component.
The plastic bearing slides (rotates) in between the tibial tray and femoral component, which allows this artificial knee joint to move.
When is it used? A doctor uses these devices in a patient who needs a total knee replacement due to osteoarthritis; primary or secondary traumatic arthritis; avascular necrosis of the femoral condyle; or a moderate varus, valgus or flexion deformity of the knee. Examples of these include, respectively:
- Wearing out of the knee joint due to age;
- Wearing out of the knee joint due to damage sustained from a physical injury;
- Lack of blood flow to the lower end of the thigh bone resulting in weakened and dead bone tissue; and
- Moderate bow-legged, knock-kneed, or bending abnormality of the knee.
What will it accomplish? The NexGen ® LPS-Flex Mobile Bearing Knee and LPS-Mobile Bearing Knee will:
- Reduce pain by replacing the painful portion of the knee joint;
- Restore alignment of the knee joint; and
- Restore movement of the knee joint.
When shouldn't it be used? A doctor should not use the NexGen ® LPS-Flex Mobile Bearing Knee or LPS-Mobile Bearing Knee in a patient who has:
- Previous history of infection in the affected joint and/or local/systemic infection that may affect the prosthetic joint;
- Insufficient bone stock on femoral or tibial surfaces;
- Skeletal immaturity;
- Neuropathic arthropathy;
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb,
- A stable, painless arthrodesis in a satisfactory functional position; or
- Severe instability secondary to the absence of collateral ligament integrity.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060037