Although hip replacements can often help individuals live with their disabilities, some products can lead to serious health complications and can put the patient in danger. Compared to older ceramic and plastic models, the metal-on-metal models were supposed to be more stable, less prone to dislocation, and longer-lasting. However, two popular hip replacement manufacturers, Stryker Corporation and DePuy Orthopedics, issued recalls within the last few years for metal-on-metal devices due to high early failure rates and serious health effects.
In 2011, the FDA instructed producers of metal-on-metal hip implants to conduct studies of patients who received the devices to determine whether the implants are shedding high levels of metallic debris. This year, the FDA issued an updated public health communication stating that MoM devices “have unique risks in addition to the general risks of all hip implants.”
Metal-on-metal hip devices have been a source of debate over the past few years, as research has linked the implants to serious risks such as the following:
- Metallosis (build-up of metal debris in soft tissue of the body)
- Implant loosening
- Device failure
- Prolonged swelling
- Need for revision surgery.
In June 2008, the FDA approved Stryker’s Rejuvenate system, and the ABG II system received FDA approval in November 2009. Both systems were approved through the FDA’s 510(k) Premarket Notification Process, which allows a drug or medical device to be offered to the public without having to undergo clinical trials. The drug or product, however, must be substantially similar to a product that has already received FDA approval.
In April 2012, Stryker issued an Urgent Field Safety Notice for Corrective Action for its Rejuvenate Modular Stems and Necks. The company noted that there were potential risks associated with fretting and corrosion at the modular neck junction. Deterioration or corrosion at this junction may lead to increased metal ion generation in the surrounding joint space and can potentially cause damage to bone and/or soft tissue surrounding the implant and joint.
Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems in July 2012 due to the systems’ potential for fretting and corrosion. As of July 2012, there were 45 reports of adverse events from patients who say the devices caused pain and/or tissue swelling.
DePuy Orthopaedics, a division of Johnson & Johnson, created the ASR XL Acetabular Hip System and the ASR Hip Resurfacing System for younger, more active patients.
In 2009, the FDA confidentially notified DePuy that it was turning down the company’s application to sell the resurfacing device in the United States. Agency reviewers found problems with study data submitted by DePuy to support its claim that the artificial hip resurfacing system was safe and effective. The FDA requested added safety data if DePuy wanted to pursue its application. The product’s sister model, the ASR total hip replacement, received FDA clearance in 2005 through a different regulatory procedure that did not mandate clinical studies of the device.
According to the FDA, on August 24, 2010, “there was a voluntary recall of the DePuy ASR TM total hip system because of new, unpublished data from the UK joint registry indicating the revision rates within 5 years were approximately 13 percent.” The FDA has received nearly 17,000 reports of problems with the implants, which sometimes require patients to undergo invasive surgery to receive a replacement device.
If you or a loved one has suffered a needless, catastrophic injury as a result of Stryker or DePuy hip replacement systems, the attorneys at Newsome Melton LLP can help you seek the compensation—and justice—you and your family deserve.