The FDA cleared the DePuy ASR Acetabular Cup System for use in traditional hip replacement in 2005. The device was cleared through a process that did not require it to undergo clinical trials. Since the beginning of 2008, the FDA has received about 300 complaints regarding the DePuy ASR cup involving patients in the US. Most of the DePuy lawsuit plaintiffs had to undergo an operation to have the device replaced soon after getting it.
The DePuy ASR is a large diameter, metal-on-metal hip replacement system. Metal-on-metal hip implants, which were introduced about a decade ago, have ball-and-socket joints that are made from metals like cobalt and chromium. They became popular because it was thought that metal-on-metal would be more durable than earlier types of implants.
According to a report in The New York Times, such hip implants have been used in about one-third of the approximately 250,000 hip replacements performed annually in this country. However, many of the nation’s leading orthopedic surgeons have reduced or stopped use of these devices because of concerns that they can cause severe tissue and bone damage.
No one knows why the DePuy ASR hip implant is prone to early failure. According to The New York Times, studies in recent years indicate that metal-on-metal devices can quickly begin to wear. This creates a large amount of metallic debris that is absorbed into a patient’s body. The metallic debris can cause inflammatory reactions that lead to pain in the groin, death of tissue in the hip joint and loss of surrounding bone.
The same New York Times article said some orthopedic surgeons have also asserted that the DePuy ASR hip implant, – which is shallower than some similar devices – has a design flaw that made it difficult to implant, an allegation DePuy had denied.
DePuy withdrew the ASR hip from the Australian market in December 2009 and indicated a plan to phase the device out worldwide in 2010. However, the company did not issue a recall of the DePuy ASR hip implant, instead insisting it was being removed from the market due to slow sales.
Then, in a letter dated March 6, 2010, DePuy warned doctors that recently analyzed data from Australia suggested that the ASR had a higher-than-expected failure rate when used in traditional hip replacement on certain types of patient. According to the letter, patients of small stature, a group that typically includes women and patients with weak bones, faced the highest risk.
Symptoms of a DePuy ASR hip implant failure could include:
- Unexplained Hip Pain
- Thigh Pain or Groin Pain
- Pain with Walking
- Pain Rising from a Seated Position
- Pain with Weight Bearing
If you experienced such symptoms within a few years of hip replacement surgery, you should make an appointment to see an orthopedist immediately. There is a high chance you were the recipient of a DePuy ASR Acetabular Cup System that has failed prematurely. If it did happened to you, don’t keep silent and assert your legal rights by way of instituting a DePuy ASR lawsuit. Our professional law firm will fight for you.