DePuy Orthopaedics, Inc., said 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 requiring 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New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12% for the ASR™ Hip Resurfacing System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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports – had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.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 families 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™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S.  The ASR™ 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. http://tinyurl.com/353d4bv

And: DePuy Orthopaedics, a division of Johnson & Johnson (JNJ), has received a Food and Drug Administration warning letter regarding unapproved marketing of a surgical-assist software system and off-label promotion of a hip-implant product.

The FDA letter, dated Aug. 19 and sent to DePuy President David Floyd, asserts DePuy has been selling its TruMatch Personalized Solutions System, a scanning device that helps surgeons determine knee implant placement prior to surgery, without submitting a premarket approval application. The agency is requiring DePuy to submit a premarket approval application for an official review and decision on whether the device can be legally marketed.

FDA officials have also told DePuy to cease off-label marketing of its Corail Hip System. The system is approved for certain kinds of hip-replacement surgery. But, according to the FDA, the product is also being marketed for other uses by DePuy through an online brochure.

The FDA has given DePuy 15 working days to submit a plan of action for correcting the violations for TruMatch and Corail. DePuy officials said they are reviewing the FDA letter and will respond to the agency's request for information. http://tinyurl.com/2u7tb5z
 


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