The device is the ASR™ XL Acetabular Hip System made by DePuy Orthopaedics.
The device is made of chromium and cobalt. It consists of a cup that's implanted into the hip with a ball joint that connects to the leg.
Experts say 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. Plus, metal particles can shave off and get into the patient's tissue and bloodstream.
ABC11 Eyewitness News investigative reporter Steve Daniels spoke with patient Alison Pulito who has the device implanted.
The 48-year-old mother of two says she's always had hip problems.
"I had childhood dysplasia in my hip," she explained. "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."
As a former healthcare consultant, Pulito really researched her options and chose the DePuy system. The Johnson & Johnson subsidiary began making the ASR™ XL Acetabular in 2003. It was co-developed by then Duke 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 Duke surgeon Dr. Michael Bolognesi.
Bolognesi is director of surgery at the Duke 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."
And that's exactly how the ASR system has been marketed worldwide - for active, younger patients like Pulito.
"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," she recalled.
But five months after the operation, Pulito 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.
Medical registries around the world report hundreds of patient complaints.
Among the complaints? The system fails and has to be re-implanted.
The national joint registry of England and Wales showed that within 5 years of a surgery, both implants failed 12 percent of the time. That means 12,000 patients may need more implant surgeries.
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.
Now, DePuy is recommending patients have a blood test to check for high levels of chromium and cobalt - even as they, and Johnson & Johnson, 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.
The I-Team wanted to know if the devices' failure rate showed up during the company's pre-market testing.
After digging through federal government files, we learned the FDA cleared the device 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.
Just last week, 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.
And in August, DePuy issued a recall of its ASR hip implant systems made after 2003.
"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 our inquiry, DePuy sent ABC11 a statement about the hip replacement system. It says it issued 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."
More on the recall can be found at http://www.depuy.com/
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