HOW DID THEY GET APPROVAL?
Birmingham Hip Resurfacing (BHR) System PMA Approval P040033a
BHR APPROVAL SUMMARY P040033b
BHR Labelling P040033c
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: Birmingham Hip Resurfacing (BHR) System
Manufacturer: Smith & Nephew, Inc
Address: 1450 Brooks Road, Memphis, Tennessee 38116
Approval Date: May 9, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040033a.pdf
What is it? The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head (ball) is removed to implant the femoral head resurfacing component.
How does it work? The BHR 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 BHR 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 BHR 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 BHR System relieves pain and improves hip function.
When should it not be used? The BHR System should not be used in a patient who:
- Has an infection of the body or blood.
- Has bones that are not yet fully grown.
- Has any blood vessel-related disease, muscle-related disease, or nerve-and-muscle-related disease that will prevent the artificial hip joint system from remaining stable, or that may prevent following instructions during the recovery period.
- Has bones that are not strong enough or healthy enough due to:
- severe bone loss (osteoporosis) or a family history of severe bone loss;
- bone loss, such as avascular necrosis, affecting more than half of the femoral head; or
- multiple fluid-filled cavities (cysts) greater than 1 centimeter in the femoral head.
- A test, such as DEXA scan, may be needed to determine the level of bone loss.
- Is female and of child-bearing age. It is unknown whether metal ions released by the device could harm an unborn child.
- Has a kidney with significantly impaired function. The patient will need testing (creatinine, GFR, BUN) before and/or after surgery to test the kidneys.
- Has had reactions to wearing metal jewelry (metal sensitivity).
- Has a suppressed immune system due to diseases such as AIDS, or is receiving high doses of corticosteroids.
- Is severely overweight.
Your doctor will need complete information about your overall health to determine whether the BHR system is right for you. You should tell your doctor about any health problems, even if they are not related to the hip, because some medicines and diseases (such as diabetes) can affect kidney or bone strength.
Additional information: Summary of Safety and Effectiveness and labeling will be available at:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p04003