DePuy Orthopaedics, Inc. Statement on
Discontinuation of ULTAMET Metal-on-Metal and
COMPLETE Ceramic-on-Metal Hip Systems

DePuy Orthopaedics, Inc., announced its decision
to discontinue sales of its ULTAMET
Metal-on-Metal Articulation and COMPLETE
Ceramic-on-Metal Acetabular Hip System
worldwide. The discontinuation will be effective
August 31, 2013. This will allow surgeons to
plan accordingly for upcoming surgeries. The
ceramic head used in COMPLETE will continue to
be available for use in other bearing surface
combinations.

The metal liner that is being discontinued
is used in both ULTAMET and COMPLETE. The liner
is designed exclusively for use with DePuy’s
PINNACLE Acetabular Cup System, the PINNACLE
Cup is not impacted by this discontinuation.
The PINNACLE Cup System is one of the most
widely used and clinically successful modular
acetabular systems for hip replacement and will
continue to be offered with both medical-grade
plastic and ceramic liners.

The decision to discontinue ULTAMET and
COMPLETE was made in conjunction with an ongoing
review of DePuy’s product portfolio. Other
worldwide product discontinuations will be
announced throughout 2013 and 2014 that will
simplify and streamline DePuy’s portfolio by
focusing on fewer, worldwide strategic product
platforms that meet patient and clinician needs
and ensure long-term growth.

DePuy made the decision to discontinue these
products because of low clinician use of ULTAMET
and COMPLETE, the availability of other options
that meet the clinical needs of patients, and
proposed changes in FDA regulation of the entire
class of metal-on-metal products, which includes
ULTAMET.

Clinician use of ceramic-on-metal and
metal-on-metal bearings is extremely low and not
expected to increase. In the United States and
Europe in 2012, metal-on-metal bearings
comprised less than two percent of the bearings
implanted.¹. This represents a 90
percent decline in industry sales since 2007.
Industry sales of ceramic-on-metal bearings have
been low since their introduction to the market.
Consistent with this overall market trend,
ULTAMET and COMPLETE brands now represent less
than one percent of DePuy bearings sold in these
markets.

Advancements in polyethylene bearing
technology and the recent approval of next
generation options that meet the clinical needs
of patients also contributed to this decision.
Physician preferences have shifted toward
metal-on-polyethylene, ceramic-on-polyethylene
and ceramic-on-ceramic bearings. These options
include the newly approved CERAMAX Total Hip
System with BIOLOX delta Ceramic-On-Ceramic
36MM Large Femoral Head for use with the
PINNACLE Acetabular Cup System. Physician use of
ceramic-on-ceramic (CoC) bearings is widespread
in Europe where, in 2012, CoC represented over
one in five bearings used.² CoC
bearings also have considerable growth potential
in the U.S. where new options are coming to
market.

Another factor in the decision to discontinue
ULTAMET is the proposed regulatory change by the
U.S. Food and Drug Administration (FDA), which
announced in January that it plans to require
all metal-on-metal hip replacements with
existing 510(k) clearances to be approved
through the Premarket Approval (PMA) process.
ULTAMET was first cleared for sale through the
510(k) process in 2000. DePuy will continue to
invest in new bearing technologies like ceramic
and polyethylene technologies. Investing
resources to seek and maintain a PMA in low-use
brands like ULTAMET and COMPLETE does not align
with this long-term strategy. DePuy has
communicated to the FDA its decision not to
pursue a PMA submission for ULTAMET.

The decision to discontinue these products is
not related to safety or efficacy, and is not a
recall. ULTAMET and COMPLETE are backed by
clinical data showing they are safe and
effective options for patients who are
candidates for hip replacement. As with all of
our products, DePuy will continue to closely
monitor the performance of ULTAMET and COMPLETE.
DePuy reviews performance data from a variety of
sources, including published and unpublished
data from national joint registries, published
literature, company-sponsored clinical trials
and internal complaint data. This includes the
FDA’s industry wide post-market surveillance of
metal-on-metal hip systems.

DePuy is communicating this decision to
surgeons, hospitals and other interested
parties. Clinicians and patients can learn more
by visiting
and
.

The ULTAMET and COMPLETE products include two
components used during hip replacement surgery:
a cup liner and a femoral head. Both products
use the same metal liner, which sits in a metal
cup that is placed in the pelvis, but each uses
different femoral heads. These heads attach to
stems that are inserted into the femur during
surgery. ULTAMET includes a metal head that
rotates inside the metal liner in the pelvis,
whereas COMPLETE uses a ceramic head. Only the
metal liner used in these products is being
discontinued.

DePuy is committed to continuing to provide
surgeons the choices and options they need to
help patients who are candidates for hip
replacement surgery. The PINNACLE Cup System has
among the broadest and most advanced options
available on the market today and a demonstrated
track record of helping to reduce pain and
restore mobility for patients suffering from
chronic hip pain.

Sources:
^1. Based on multiple sources
including ONN, Industry Surveys and Management
Estimates
^2. Source: European Markets For Large
Joint Reconstructive Implants. Millenium
Research Group: March 2013.