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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Trilogy AB Acetabular System
PMA Applicant: Zimmer, Inc.
Address: P.O. Box 708, Warsaw, IN 46581-0708
Approval Date: June 28, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040048a.pdf
What is it? The Trilogy AB Acetabular System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint.
How does it work? The Trilogy AB Acetabular System consists of:
- A metal hip stem, that a doctor places into a hole drilled in the end of the thigh bone;
- A ceramic, ball-shaped part (femoral head) that attaches to the hip stem;
- A metal, socket-shaped part (acetabular cup) implanted into the pelvis that the femoral head fits into; and
- A ceramic insert that fits into the acetabular cup.
The ceramic femoral head slides around in the ceramic insert, which allows this artificial hip replacement system to move.
When is it used? The Trilogy AB Acetabular System is for patients who need a total hip replacement because of painful non-inflammatory arthritis. Examples of non-inflammatory arthritis are:
- Wearing out of the joint due to time/use, (osteoarthritis),
- Lack of blood flow to the bone (avascular necrosis), or
- Joint damage due to injury (traumatic arthritis).
What will it accomplish?The Trilogy AB Acetabular System is used to relieve pain and allow for increased function in the hip.
When should it not be used? The Trilogy AB Acetabular System should not be used in patients with:
- insufficient quantity or quality of bone support,
- neurological or muscular conditions that would place extreme load or instability upon the hip joint,
- active joint infections or chronic systemic infections,
- skeletal immaturity.
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=p040048