Voluntary Market Withdrawal of Hip Component

On June 1, 2012, Smith & Nephew, an orthopedic firm headquartered in the U.K., issued a press release stating that the company is voluntarily recalling an optional metal liner used in its all-metal hip system, the R3 Acetabular System. According to the company, since the recalled metal hip liner was put on the market in 2007, about 7,700 of these hip components have been implanted in patients.

According to an article published by Reuters, Smith & Nephew’s decision to withdraw the metal liner came as a result of evidence showing that patients implanted with the hip component experienced higher than normal problems. The recall also came as a result of studies indicating that 1.6 percent of patients with the R3 Acetabular System had to undergo revision surgery each year. This revision rate is higher than the 1 percent guideline put forth by the U.K.’s National Institute for Health and Clinical Excellence.

A spokesperson for Smith & Nephew indicated that patients who had problems with the recalled metal hip liner had experienced dislocations, infections, and fractures. However, the spokesperson stated that there were no indications of metallosis, or metal debris in the body. Although Smith & Nephew stated that the problems associated with its recalled metal liner were different from those associated with all-metal implants, this recent recall reinforces the growing concern with metal-on-metal hips.

See the full Smith & Nephew press release at:

See the full Reuters article at:

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