DuraSeal Spine Sealant System - P030042
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: CONSERVE® Plus Total Resurfacing Hip System
PMA Applicant: Wright Medical Technology
Address: 5677 Airline Road, Arlington, Tennessee 38002
Approval Date: November 3, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030042a.pdf
What is it? The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because only the surface of the ball (femoral head) is removed to implant the femoral head resurfacing component.
How does it work? The CONSERVE® Plus Total Resurfacing Hip System has two parts: a socket in the shape of a shallow cup (acetabular component), and a cap in the form of a ball head (femoral resurfacing component).
- The cup replaces the damaged surface of your hip socket (acetabulum).
- The cap covers the ball-shaped bone at the top of your thigh (femoral head), and the cap has a small stem that is inserted into the top of your thighbone.
The cap moves within the cup. The surfaces that rub against each other (the bearing couple) are made from highly-polished metal. This type of bearing couple is called a metal-on-metal bearing couple.
When is it used? The CONSERVE® Plus Total Resurfacing Hip System relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. Degenerative joint diseases include osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis.
The CONSERVE® Plus Total Resurfacing Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
What will it accomplish? The CONSERVE® Plus Total Resurfacing Hip System is intended to relieve pain and improve hip function.
When should it not be used?
- Patients with active or suspected infection in or around the hip joint.
- Patients who are skeletally immature.
- Patients with bone stock inadequate to support the device including:
- Patients with severe osteopenia should not receive the CONSERVE® Plus Total Resurfacing Hip procedure. Patients with a family history of severe osteoporosis or severe osteopenia;
- Patients with osteonecrosis or avascular necrosis (AVN) with greater than 50% involvement of the femoral head (regardless of FICAT Grade) should not receive a CONSERVE® Plus Total Resurfacing Hip System device; or
- Patients with multiple cysts of the femoral head (greater than1cm) should not receive a CONSERVE® Plus Total Resurfacing Hip System device .
- NOTE: In cases of questionable bone stock, a Dual-Energy X-ray Absorptiometry (DEXA) scan may be necessary to assess inadequate bone stock.
- Patients with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- Females of child bearing age due to unknown effects of metal ion release on the fetus.
- Patients with known moderate or severe renal insufficiency.
- Patients who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids.
- Patients who are obese and/or with a BMI greater than 35.
- Patients with known or suspected metal sensitivity (such as with jewelry).
Additional Information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfTopic/ pma/pma.cfm?num=P030042
- MedlinePlus - Hip Injuries and Disorders
- MedlinePlus Tutorial - Hip Replacement
- American Academy of Orthopaedic Surgeons - Activities After Hip Replacement