Metal-on-Metal Hip Implants Recalled
Getting a hip replacement can be scary. You have to trust your doctors to give you the best options to help you feel good and get you back on your feet again. Yet, for some patients, the process of getting back on their feet led to excruciating pain and other health problems.
Over the last several years, several manufacturers have created metal-on-metal hip implants that have been used in thousands of patients. Many of these patients have experienced intense pain as a result of device defects, leading to further scrutiny of these medical devices.
The Facts: DePuy and Zimmer Hip Implants
- DePuy Orthopaedics Inc. (a division of Johnson & Johnson) issued a voluntary recall of the ASR Hip Resurfacing System and the ASR XL Acetabular System in 2010 after reports surfaced of problems with the devices, including severe pain and potential exposure to metal poisoning. The resurfacing system was not used in the United States.
- Zimmer Holdings removed its Durom Acetabular Component (Durom Cups) from the market in 2008 after reports that the devices were slipping out of place and causing excruciating pain in patients.
- In February 2011, the FDA issued a warning that metal-on-metal hip implants carried “unique risks” because metal shavings can wear off and damage nearby tissue. Patients were advised to monitor and report symptoms.
- Three months later, the FDA issued an order requiring all manufacturers of metal-on-metal hip replacements to test patients who had received these devices. The order stressed testing for metal poisoning.
- Registry data from the United Kingdom shows that up to 50 percent of patients with the DePuy hip implants have to undergo revision surgery within six years.
- The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning about the appearance of soft-tissue necrosis (tissue death) among some patients with metal-on-metal hip implants.
- The agency also reported failure rates of 13 percent for the DePuy ASR XL Acetabular System, and said that approximately 1 in 8 patients implanted with ASR devices needed corrective surgery within 5 years of receiving the implant.
Defective DePuy and Zimmer Hip Implants
Many problems have been reported with metal-on-metal hip implants manufactured by both DePuy and Zimmer. Two primary problems have been reported in both hip implants:
- Improper fit between the metal ball and metal socket in the hip implants, resulting in a loose fit or in the ball falling out of the socket.
- Friction between the metal ball and metal socket resulting in metal shavings being released into the blood, potentially causing metal poisoning or painful inflammation and damage to nearby muscle and tissue.
In addition to the damage that metal shavings can cause to muscle, bone, and tissue in the body, the FDA warns that high levels of metal ions in the body can also lead to neurological and cardiac disorders.
The symptoms experienced by patients who develop these side effects from hip implant failure can be severe and debilitating. Some symptoms include:
- Pain in the hip, groin, or leg
- Difficulty moving or walking
- Swelling at or near the implant site
If any of these symptoms are experienced, imaging tests can show whether the implant has a proper fit, and blood tests can show any increase of metal ions in the blood.
As many as 13 percent of patients who received DePuy implants needed revision surgery after receiving the devices, some within 5 years, according to the MHRA data. As many as 5.7 percent of patients who received the Zimmer implants needed it, according to the manufacturer. Traditional hip implants should last about 15 years before they wear out and need to be replaced – requiring revision surgery – and the average failure rate for all devices before that time is only about 3 percent, according to the MHRA data.
Defective Hip Implants Lawsuits
The FDA approved DePuy metal-on-metal hip implants in 2005, and since then, an estimated 40,000 people in the U.S. and 93,000 people worldwide have received them. Zimmer Holdings received FDA approval for its Durom Cups in 2006, and since then, an estimated 12,000 people in the U.S. have received them.
Tens of thousands of people are potentially at risk for developing painful and debilitating side effects from these defective metal-on-metal hip implants and may require additional surgery to replace them.
Adding insult to injury, the DePuy hip implants were approved through a regulatory loophole that does not require evidence of safety or efficacy. The 510k approval method through the FDA only requires that the device is shown to be “substantially similar” to other devices already on the market – it does not require any evidence of clinical trials or human testing. The FDA does not conduct independent testing for such applications.
There are currently thousands of lawsuits filed against the manufacturers of these defective metal hip implants.
North Carolina Hip Implant Lawyers
Did you receive a hip implant between 2005 and 2010? It could be a DePuy or Zimmer metal hip implant, and you could be eligible to receive compensation under the law. If you received one of these metal hip implants, or if you are experiencing pain that you believe to be the result of your hip implant, one of the North Carolina defective medical device lawyers at the Law Offices of James Scott Farrin may be able to help. Call 1-866-900-7078 or chat with one of our representatives online. Our firm offers you a free evaluation of your case, and we have representatives available to answer your questions 24 hours a day, 7 days a week. Don’t accept a life of pain. Find out if we can fight to get you the compensation you may deserve!
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