DePuy Orthopaedics Voluntarily Recalls ASR(TM) Hip System

WARSAW, Ind., Aug. 26 /PRNewswire/ — DePuy Orthopaedics, Inc., announced it is
voluntarily recalling the ASR(TM) XL Acetabular System and DePuy ASR(TM) Hip
Resurfacing System used in hip replacement surgery due to the number of patients
who required a second hip replacement procedure, called a revision surgery.

The majority of ASR hip replacement surgeries have been successful. However, the
company is advising patients with an ASR device to visit their surgeons for
evaluation of their implant performance. Yearly monitoring is recommended to
ensure the ASR hip replacement is functioning well, even in the absence of
symptoms.

New, unpublished 2010 data from the National Joint Registry (NJR) of England and
Wales shows a five-year revision rate of approximately 12% for the ASR(TM) Hip
Resurfacing System and approximately 13% for the ASR(TM) XL Acetabular System.
These revision rates are across the entire size range. The risk for revision was
highest with ASR head sizes below 50 mm in diameter and among female patients.
Previous post-market surveillance data from a variety of sources – including
national joint replacement registries, published literature, company sponsored
clinical trials, internal complaints data and unpublished clinical research
reports – had shown lower revision rates and that the ASR hip was performing in
line with other devices in its class.

“We regret that this recall will be concerning for patients, their family
members and surgeons,” said David Floyd, president, DePuy Orthopaedics. “We are
committed to assisting patients and health care providers by providing
information through multiple channels and paying for the cost of doctor visits,
tests and procedures associated with the recall.”

DePuy intends to cover reasonable and customary costs of monitoring and
treatment for services, including revision surgeries, associated with the recall
of ASR.

DePuy is providing hospitals, surgeons and patients with comprehensive
information about the recall to help them determine next steps. Patients and
health care professionals with questions related to this recall should visit
depuy.com. As of August 27, patients in the U.S. and Canada can contact DePuy by
calling 888-627-2677 Monday-Saturday, 8 a.m. to 9 p.m. EST. Patients in other
countries can place a collect call to the U.S. at +1 813-287-1651 24 hours a
day, seven days a week.

The ASR device is part of a class of large diameter, monoblock hip resurfacing
and replacement devices often selected by surgeons for younger patients who may
benefit from a more stable device that can reduce the chances of dislocation
after surgery. The DePuy ASR(TM) Hip Resurfacing System was introduced in 2003
and is only approved for use outside the U.S. The ASR(TM) XL Acetabular System
was first launched in 2004 and has been available worldwide.

Very few devices remain on the worldwide market. DePuy decided in 2009 that it
would be discontinuing the ASR System as a result of declining demand and the
intention to focus on the development of next generation hip replacement and
resurfacing technologies that best meet the needs of surgeons and patients.

DePuy has notified the U.S. Food and Drug Administration and other regulatory
agencies globally of the voluntary recall.

About the DePuy Companies

DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global
provider of orthopaedic devices for hip, knee, extremities and trauma, as well
as bone cement and operating room products. It is part of the DePuy Family of
Companies, which has a rich heritage of pioneering a broad range of products and
solutions across the continuum of orthopaedic and neurological care. These
companies are unified under one vision – Never Stop Moving(TM) – to express
their commitment to bring meaningful innovation, shared knowledge and quality
care to patients throughout the world. Visit www.depuy.com for more information.

(This press release contains “forward-looking statements” as defined in the
Private Securities Litigation Reform Act of 1995. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from DePuy Orthopaedics, Inc. and/or Johnson & Johnson’s
expectations and projections. Risks and uncertainties include general industry
conditions and competition; economic conditions, such as interest rate and
currency exchange rate fluctuations; technological advances and patents attained
by competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms and
governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties and
other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on
Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K,
as well as subsequent filings, are available online at www.sec.gov, www.jnj.com
or on request from Johnson & Johnson. Neither DePuy Orthopaedics, Inc. nor
Johnson & Johnson undertake to update any forward-looking statements as a result
of new information or future events or developments.)