New, York, NY”June 12, 2012”Smith & Nephew recently annouced a voluntary recall of its metal socket liner, which is used with its R3 Acetabular System hip device. An estimated 7,700 metal socket liner have been implanted in patients since it was released in the market in 2009.
Clinical studies on Smith & Nephew’s R3 Acetabular System hip device used with the metal socket liner for stemmed total hip replacements have concluded that the annual revision rate in patients is 1.6%. This is .6% higher than the acceptable annual revision rate set by Britain’s drug and device regulatory body.
According to Smith & Nephew, the metal socket liner has been associated with causing injuries such as infections, fractures, and dislocations. Smith & Nephew contends though that there is no evidence of their metal socket liner and R3 Acetabular System hip device being associated with delivering metallic debris in the body as some other Metal-On-Metal hip devices have been.
Recent reports from the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the American Academy of Orthopedic Surgeons have highlighted the potential dangers of all-metal artificial hip systems. In recent months, the Food and Drug Administration (FDA), has cited these new reports on Metal-On-Metal hip replacements, in its consideration of stricter regulations on these types of devices.