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.

• 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.

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.

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.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040033.html

Other:

• Comprehensive hip implant website; some examples are listed below:
  http://www.nlm.nih.gov/medlineplus/hipinjuriesanddisorders.html#diagnosissymptoms

• Slide show on hip replacement (must have Adobe Acrobat Reader to access):
  http://www.nlm.nih.gov/medlineplus/tutorials/hipreplacement.html
• Illustrated hip replacement:
  http://www.nlm.nih.gov/medlineplus/ency/presentations/100006_1.htm

• Comprehensive list of things to help after hip surgery:
  http://orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=274&topcategory=Hip

• Diet, home safety tips to avoid hip injury:
  http://orthoinfo.aaos.org/brochure/thr_report.cfm?Thread_ID=25&topcategory=Hip

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page