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.
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."