Smith & Nephew ($SNN) says its pulling an optional metal part used with its R3 hip replacement cup from the market, because it is dissatisfied with how the product performs clinically. Investors reacted harshly, driving the stock down by about 3% in early trading.
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. 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.
"We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component," Chief Medical Officer Andy Weymann explained in a statement, without elaborating on specific problems.
A Smith & Nephew spokesman told FierceMedicalDevices 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, according to the spokesman, 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 procedures using the part generated less than 1% of Smith & Nephew's global hip implant revenue.
The R3 system itself has been an issue for the company in the past. Back 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 hadn't 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.)
- read the release