Smith & Nephew Voluntary Withdrawal of Metal Hip Liner

Smith & Nephew PLC said Friday that it is pulling a metal liner used in hip replacements from the market. The London company said the device is the optional metal liner for its R3 Acetabular System hip devices. Smith & Nephew said it is "not satisfied with the clinical results" of the liner because some patients needed an additional surgery to have the liner removed. It described the move as a precaution.

The U.K.-based device and medical technology company disclosed what it termed as a "voluntary market withdrawal" of an "optional metal liner component" for its R3 Acetabular system, which serves as the "socket" portion of a hip implant. The withdrawal encompasses the optional metal liner, or cup, component. Surgeons, however, will still be able to use the system using alternative non-metal liners and the company said it did not anticipate any delays to surgery.

A small number of patients experienced problems including infections, fractures and dislocations - but there was no evidence of "metallosis", or the build-up of metallic debris in the body, a corporate spokesman said. The veracity of this statement is yet to be determined.

Smith & Nephew said about 7,700 metal liners have been implanted since the piece first became available in 2007, mostly for stemmed total hip replacements. The component launched globally in 2009. Patients who have the liner as part of their implant are being urged to talk to their surgeons if they are dealing with any unusual symptoms.

A Smith & Nephew spokesman said that U.S. and European regulators have been notified of the company's voluntary action, which was based on clinical data from multiple sources. Among them: The U.K. National Joint Registry shows a revision rate of 6.3% after four years for the part, and the Australian National Joint Replacement Registry shows a revision rate of 4.96% after two years.

The company cautioned in its statement that other R3 system liners, made of polyethylene (and ceramic outside the U.S.) aren't affected by the market withdrawal. Smith & Nephew also downplayed the impact it would face taking the component off the market, noting that the company reported $4.27 billion in revenue in 2011 and claims less than 1 percent of that revenue came from procedures involving the recalled component.

The R3 system itself has been an issue for the company in the past. In December of 2010, the FDA issued Smith & Nephew a warning letter regarding the company's Tuttlingen, Germany facility that produces the implant. The FDA said that the company had not performed adequate tests and that it failed to establish and maintain a process that would correct manufacturing problems. At the time, Smith & Nephew said it took initial action to resolve any FDA issues. (Other sites in the U.K. and U.S. also manufacture the device.)

The voluntary recall will only add to concerns about the safety of metal-on-metal hips. Metal-on-metal hips were developed to be more durable than traditional implants, which combine a ceramic or metal ball with a plastic socket. Smith & Nephew, through a company spokesman said the issues with its system were different to those seen with some other all-metal implants, such as the high-profile recall of the DePuy metal-on-metal ASR system.

If you or a loved one have had hip replacement surgery and have been implanted with a defective Smith & Nephew R3 Acetabular system, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with the Smith & Nephew R3 metal liner. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or at booths@pittmandutton.com.