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Tragic Discovery of Hip Replacement Failures

Thousands of Hip Replacement Systems Recalled by Johnson & Johnson’s DePuy Orthopaedics

J&J already in slew of trouble with FDA faces more problems with its subsidiary’s recall of hip replacement and hip resurfacing systems worldwide

August 26, 2010 – DePuy Orthopaedics, Inc., a Johnson & Johnson company, announced today the voluntarily recall of 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, the company says.  However, the company is advising patients with an ASR device to visit their surgeons for evaluation of their implant performance. Yearly monitoring is recommended by DePuy to ensure the ASR hip replacement is functioning well, even in the absence of symptoms.

The acetabular system, which was launched in 2004, is sold worldwide. The resurfacing system, introduced in 2003, is only sold outside the U.S.

New, unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System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.  This means these percentages of patients went back for additional surgery to correct problems with these systems.

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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports – had shown lower revision rates and that the ASR hip was performing in line with other devices in its class.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 says it 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. 

DePuy just received FDA order to stop selling Corail Hip System

Just days before this recall, the Food and Drug Administration told DePuy to stop selling its Corail Hip System for two unapproved uses, according to the Associated Press.

“It also ordered the company to provide information needed to review another product the agency said DePuy has been selling even though it was never approved. It's called the TruMatch Personalized Solution System, and uses software and high-tech CT scanning technology to create a 3-D view of a patient's knee to help a surgeon position a knee implant,” the AP reported.

Johnson & Johnson’s FDA problems

“Johnson & Johnson remains under scrutiny by the FDA, Congress and federal prosecutors over eight previous U.S. recalls of nonprescription medicines since last September,” according to the AP.

“Those included millions of bottles of Tylenol, other pain relievers and cold medicines for children and adults, for problems including bacterial contamination and tiny metal savings found in some bottles.”

CNN reports that Johnson & Johnson’s “drug making unit, McNeil Consumer Healthcare, which makes well-known cold and pain drugs such as Tylenol and Benadryl, has received negative inspection reports and warning letters tied to manufacturing lapses at its U.S. factories.

“In May, McNeil shut a plant in Fort Washington, Penn., after the company recalled millions of children's Tylenol and other over the counter drugs.”

What patients should do

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.

About the DePuy Companies

DePuy Orthopaedics, Inc., a Johnson & Johnson company, is a leading global provider of orthopedic 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.

About Hip Replacement
(Hip arthroplasty)

Hip replacement is surgery for people with severe hip damage. When you have a hip replacement, the surgeon removes damaged cartilage and bone from your hip joint and replaces them with new, man-made parts.

This can relieve pain, help your hip joint work better, and improve your walking and other movements. Your doctor may recommend it if you have hip damage and pain, and physical therapy, medicines and exercise don't help.

The most common problem after surgery is hip dislocation. Because a man-made hip is smaller than the original joint, the ball can come out of its socket.

The surgery can also cause blood clots and infections. After a hip replacement, you might need to avoid certain activities, such as jogging and high-impact sports.

>> Read more at National Institute of Arthritis and Musculoskeletal and Skin Diseases

>> Click here to Tutorial on Hip Replacement at MedlinePLUS

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