DePuy Orthopaedics Voluntarily Recalls ASR(TM) Hip System
By Depuy Orthopaedics Inc., PRNEWednesday, August 25, 2010
WARSAW, Indiana, August 26, 2010 - 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New, unpublished 2010 data from the National Joint Registry (NJR) of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unpublished clinical research reports - had shown lower revision rates and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.)
Mindy Tinsley, +1-574-372-7136, mtinsley at its.jnj.com; Lorie Gawreluk, +1-908-764-0873, lgawrel1 at its.jnj.com
Tags: August 26, Depuy Orthopaedics Inc., Indiana, United Kingdom, Warsaw