Despite considerable criticism and two years of complaints that the ASR Artificial Hip was failing, DePuy Orthopaedics, Inc. waited until August of 2010 to announce a recall. Known as the ASR XL Acetabular and ASR Hip Resurfacing System, these ASR hips have been implanted in over 93,000 patients.
Due to the premature failure of DePuy Hips, up to 12.5% (approximately one in eight) of patients may be forced to endure the pain and associated expenses of subsequent corrective surgery.
DePuy issued a field safety notice dated Jan. 15 for physicians and consumers for the ADEPT 12/14 Modular Head used in total hip replacement after reviewing its revision rates in the U.K. National Joint Registry Supplier Feedback data and the Australian Orthopaedic Association National Joint Replacement Registry.
DePuy issues field safety notice for ADEPT 12/14 metal modular head
Posted on February 18, 2013 - healio.com Orthopedics
DePuy, a Johnson & Johnson company issued a field safety notice dated Jan. 15 for physicians and consumers for the ADEPT 12/14 Modular Head used in total hip replacement after reviewing its revision rates in the U.K. National Joint Registry Supplier Feedback data and the Australian Orthopaedic Association National Joint Replacement Registry.
The notice does not apply to the ADEPT hip resurfacing femoral components, according to a DePuy spokesperson. The recall, however, involves 7,700 implants sold in 21 countries, including the United Kingdom, Germany, Denmark, Australia and Canada. The heads were not sold in the United States.
Finsbury Orthopaedics Ltd. designed, developed and manufactured the ADEPT 12/14 Modular Head in 2004. DePuy acquired the firm in 2009 and then the products were acquired by MatOrtho Ltd. in 2011. DePuy issued the field safety notice due to its responsibility for monitoring ongoing performance of the product.
"Customers have been advised through the field safety notice to discontinue use and distribution of any ADEPT 12/14 Modular Heads they may still have in stock," the DePuy spokesperson told Orthopedics Today.
The implant has a cumulative revision rate of 12.1% at 7 years, according to results DePuy officials analyzed from U.K. National Joint Registry Supplier Feedback data in November 2012. In the Australian Orthopaedic Association National Joint Replacement Registry, registry officials reported a 7.1% cumulative revision rate for the modular head at 3 years when used in total hip replacement, according to an analysis done in September 2012.
"Patients who received the ADEPT Modular Head should follow up with their doctor if they are experiencing symptoms and be treated according to local guidance/standard of care for patients receiving metal-on-metal articulations," the DePuy representative stated. "DePuy has notified customers and appropriate regulatory agencies," according to the spokesperson.
Hip Implant Recalled Amid Concerns About Heart Failure, Dementia
Posted on December 1, 2010 - Steve Daniels and Silvia Gambardella, ABC News.
A Johnson & Johnson subsidiary has recalled a metal hip implant used by thousands of younger patients after complaints of severe pain and system failure, and amid worries that the implants may be sending metal shavings into patients' bloodstreams, potentially putting them at risk for dementia and heart failure.
Experts say, however, that if a surgeon doesn't get the cup inserted at just the right angle, the two parts can rub against each other. That can cause severe pain, and metal particles may shave off and get into the patient's tissue and bloodstream.
Patient Alison Pulito told WTVD that she had the device implanted because of long-standing hip problems. "I had childhood dysplasia in my hip," explained the 48-year-old mother of two. "In my twenties, I was skiing and I fell."
Surgery to repair cartilage only gave short-term relief.
"I couldn't really walk," she recalled. "I just decided it was time to take the next step and have a hip replacement."
Pain Returned To Hip
A former healthcare consultant, Pulito thoroughly researched her options and chose the DePuy system, which was co-developed by then-Duke University surgeon Thomas Vail. ASR's chromium and cobalt metals promised to make it more durable than previous implants.
"Wear is a real problem for hip replacement. It probably causes the majority of failures over time," explained Dr. Michael Bolognesi, who is director of surgery in Duke's orthopaedic department. He scrubbed in with Dr. Vail on more than 200 ASR implants.
"Traditional hip replacement will have a metal ball and a plastic liner," he said. "Our hope would be that, with those younger patients, these hard-on-hard bearings might give them an advantage from a standpoint of wear."
"I sent emails to my surgeon saying I thank you so much for, you know, taking my pain away and giving me this opportunity to get on a bike with my kids and walk my dogs," Pulito recalled.
But five months after the operation, she says the pain was back.
"It was incredibly painful," she said.
And Pulito wasn't the only patient who had pain. DePuy says some 93,000 implants have been used in patients, and medical registries around the world report hundreds of patient complaints.
The complaints include system failure, which means the hip must be re-implanted. The national joint registry of England and Wales showed that within 5 years of a surgery, ASR implants used in those countries failed 12 percent of the time.
Another DePuy Metal-on-Metal Hip Implant Recall
According to PRWeb: Last month Johnson & Johnson initiated another DePuy recall, this time centered on its Adept line of metal-on-metal hip replacement components, according to a Feb. 14 Reuters report.* This is the second such device Johnson & Johnson has withdrawn from the market, the other being the DePuy ASR, which it recalled in August 2010. The Rottenstein Law Group notes with concern that while the device was not sold in the United States, the ASR was sold here and the evidence against the safety of metal-on-metal hip replacements in general is mounting.
Metal Shavings In Bloodstream
Some doctors say they also worry about the possibility of particles from the implants getting released into the bloodstream. That could cause deafness, dementia and heart failure.
"It's incredibly concerning," said Bolognesi.
DePuy now recommends that implant patients have a blood test to check for high levels of chromium and cobalt.
In August, DePuy issued a recall of all ASR hip implant systems made after 2003. DePuy and Johnson & Johnson also face a class-action lawsuit filed early this year.
The suit claims the company continued to aggressively market the devices for the past two years even though the FDA received hundreds of complaints about their high failure rate.
A WTVD investigation revealed that the device had been cleared by the FDA without any clinical trials. The company used a little-known regulation that allows a medical device to be approved if it's similar to another device that's already been tested.
Attorney Matt Davis represents Alison Pulito and more than 60 other patients with failed implants. "The failure rate keeps climbing year after year," he said. "It's going to continue to climb and pretty dramatically."
Pulito is among those who needed a second operation to replace the DePuy hip device.
"When he took the hip out, there was a lot of inflammation in there - just lots of swelling and tissue damage, and he thought I would do really well with the revision," she said.
But she didn't do well because of the inflammation, and needed a third operation -- costing her thousands of dollars and so much more.
"It just affects your life in every way. I have lost so many opportunities with my children and with my husband," she said.
DePuy Issues Statement
In November, lawyers representing implant patients met in Durham to talk about their cases.
"I'm pretty convinced that a number of people who have this device are going to end up in wheelchairs for the rest of their lives because the destruction process went too far," offered Davis.
"I'm angry, and I feel like this shouldn't happen in the United States. We have -- we have regulations. I think, you know, patients or consumers, we rely on our doctors, we rely on the products that they use," said Pulito. Pulito is feeling better now, but is nervous when she thinks about her future.
"You know, I can't ask the question. I think it's terrifying to think about if this one doesn't work. I can't let my mind go there, because you can just end up in a wheelchair," she said.
In response to a WTVD inquiry, DePuy issued a statement about the hip replacement system. It says it launched the voluntary recall after receiving the data from England and Wales.
DePuy says it is taking full responsibility and "intends to cover reasonable and customary costs of monitoring and treatment services, including revision surgeries."