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.