The FDA has published an information overview for the Birmingham Hip Resurfacing (BHR) System, manufactured by Memphis, Tenn.-based Smith & Nephew. The device was approved May 9.
The system is a "metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint," the document says. It is designed to relieve pain and improve hip function by replacing hip parts severely damaged by degenerative joint diseases such as osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia or avascular necrosis, the document says. It 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.
The system features two components: a socket in the shape of a shallow cup (acetabular component), which replaces the damaged surface of the hip socket (acetabulum); and a cap in the form of a ball head (femoral resurfacing component), which covers the ball-shaped bone at the top of the thigh (femoral head). The cap moves within the cup, and 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.
To view information about the device, visit http://www.fda.gov/cdrh/mda/docs/p040033.html (http://www.fda.gov/cdrh/mda/docs/p040033.html).