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For Immediate Release: June 14, 2011
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259061.htm
FDA approves first ceramic-on-metal total hip replacement system
The U.S. Food and Drug Administration approved on June 13 the first
ceramic-on-metal total artificial hip system for patients with
osteoarthritis.
Hip joints consist of bone in the shape of a ball at the top of the
thighbone (femur) that fits into a rounded socket in the pelvis (acetabulum).
During total hip replacement surgery, worn and damaged portions of bone
and cartilage are removed and replaced with an artificial hip joint.
Specifically, a shell or cup replaces the socket, a stem is inserted
into the thighbone and a femoral head or ball at the top of the stem is
fitted inside the curved artificial socket where the ball can slide
around, allowing for movement.
Previous total hip replacement systems cleared or approved by FDA have
used different combinations of metal, ceramic, and polyethylene (a form
of plastic). The Pinnacle CoMplete Acetabular Hip System is the first to
combine a ceramic ball and a metal socket.
“Orthopedic surgeons and their patients now have an additional option
for total hip replacement with the approval of the Pinnacle CoMplete
Acetabular Hip System,” said Christy Foreman, director of the Office of
Device Evaluation in the FDA’s Center for Devices and Radiological
Health.
The FDA’s approval is based on a two-year, randomized clinical trial,
which found no clinical difference between 194 patients who received the
new ceramic-on-metal system and 196 patients in a control group who
received a metal-on-metal hip implant. Two patients who received the
Pinnacle CoMplete system required a second surgery to replace their new
implant compared with three patients who required a second surgery in
the control group.
As a condition of FDA approval, the manufacturer, DePuy Orthopaedics
Inc., will conduct a postmarket study, monitoring patients receiving the
Pinnacle CoMplete system for adverse events and metal ion concentrations
in their blood.
DePuy is located in Warsaw, Ind.
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