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: Pinnacle® CoMplete® Acetabular Hip System
Manufacturer: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Drive, Warsaw, IN 46582
Approval Date: June 13, 2011
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090002a.pdf
What is it? The Pinnacle® CoMplete® Acetabular Hip System is ceramic-on-metal artificial total hip replacement system, surgically implanted to completely replace a diseased or damaged hip joint.
How does it work? The system has four parts that work together to allow the hip joint to move:
- A metal hip stem, which a doctor places into a hole drilled in the end of the thigh bone
- A ceramic, ball-shaped part (femoral head) that fastens to the metal hip stem
- A metal, socket-shaped part (acetabulum) that the ball-shaped part fits in
- A metal shell that fastens the metal socket-shaped part to the hip bone
The ceramic ball slides around in the metal socket, which allows this artificial hip joint to move.
When is it used? There are a number of reasons why a patient would undergo total hip replacement surgery. The most common reason is osteoarthritis (OA), which is a slow wear and tear of the joint. OA frequently occurs in families (genetic); however, it can also develop in a patient with no previous history of injury to the hip joint.
The Pinnacle® CoMplete® Acetabular Hip system is a single use device intended for uncemented fixation. The Pinnacle® CoMplete® Acetabular Hip System is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint disease and its composite diagnoses of osteoarthritis or post-traumatic arthritis.
What will it accomplish? The Pinnacle® CoMplete® Acetabular Hip System will reduce pain by replacing the painful arthritic hip joint, and restore its ability to move.
When should it not be used? The Pinnacle® CoMplete® Acetabular Hip System should not be implanted in patients with the following conditions:
- Active or recent infections that may spread to other areas of the body
- Insufficient bone stock that may not support hip implant components (such as, osteoporosis or severe osteopenia)
- Marked weakening or deformity in the upper femur
- Bones that have not stopped growing (skeletal immaturity), or any nerve or muscle disease that may have a negative effect on walking or weight bearing
- The presence of any known tumor-causing (neoplastic) or the spreading of cancerous cells (metastatic disease)
- The kidneys are not working very well or function is significantly impaired (chronic renal impairment or failure)
- Known allergies to metal or metal hypersensitivity
- Females of childbearing years due to the unknown effects of potentially elevated metal ions on the fetus.
Additional Information: Summary of Safety and Effectiveness and labeling are available online.