DePuy Hip CupDePuy Orthopaedics, Inc., announced it is voluntarily recalling the
ASRT XL Acetabular System and DePuy ASRT 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 Depuy 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New, unpublished 2010 data from the National Joint Registry (NJR) of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 ASRT Hip Resurfacing System and approximately 13% for the ASRT
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trials, internal complaints data and unpublished clinical research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.
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