WARSAW, Ind., Aug. 26 /PRNewswire/ — DePuy Orthopaedics, Inc.,
announced it is voluntarily recalling the ASR™ XL Acetabular
System and DePuy ASR™ 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New, unpublished 2010 data from the National Joint Registry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™ Hip Resurfacing System and
approximately 13% for the ASR™ 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clinical trials, internal complaints data and unpublished clinical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
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