DePuy Hip Replacement Lawyers
The first hip replacement procedure was performed in Germany in 1891. At the time, the artificial femoral head was constructed of ivory. Metal components were introduced in 1940. Hip implant designs continued to evolve as physicians identified – and attempted to resolve – causes of early failure. If you have suffered from a defective ASR hip, please contact us for a free consultation from one of our DePuy hip replacement lawyers.
Today, most hip replacements are composed of a one-piece acetabular component (cup), a femoral stem, and a femoral head (ball). The cup and stem are usually fixated into the bone with a special cement. The DePuy ASR XL Acetabular System is designed to be implanted without this cement. Bone is expected to grow into the acetabular and femoral pieces, and hold them in place. However, the 2010 DePuy hip recall reveals potential flaws in the prosthesis’s design.
Below, we’ll provide a brief history of the DePuy hip replacement recall, including an explanation regarding how the prosthesis gained FDA approval in the first place. We’ll address its failure rate and the manufacturer’s actions to clarify the reason many patients have filed a DePuy lawsuit.
The DePuy ASR Passes The 510(k) Approval Process
The ASR XL Acetabular System was introduced in 2004, and has since been implanted into over 93,000 patients. Most recipients assume the prosthesis underwent rigorous testing prior to being made available to the market. In reality, it did not. The FDA granted approval based on its “Premarket Notification” process, otherwise known as 510(k).
The 510(k) approval process requires medical device manufacturers to prove their products are “substantially equivalent” to similar devices already being sold. Substantial equivalence is based on several criteria. As long as the manufacturer satisfies these criteria, it can legally sell its products to orthopedists and their patients. Painstaking clinical testing to validate a given device’s safety is not required.
This is the path chosen by DePuy Orthopaedics, presumably to avoid the two to three years of lost profits that would have resulted from pursuing thorough testing. Gaining FDA approval through the 510(k) process, they released the ASR XL Acetabular System. Unfortunately, it showed signs of major problems almost immediately.
Early Failure Rates Higher Than Anticipated
A hip replacement can be expected to last for a minimum of fifteen years. While they occasionally fail prematurely, the percentage of such cases is low. It is generally under 5 percent, though several factors (for example, age) play a role. The ASR hip prosthesis began to show signs of failure within a few years of implantation. Patients complained of a variety of problems.
Some recipients noticed pain in the hip and groin area long after they had recovered from the surgery. Others reported a sensation of loosening in the joint. Still others experienced bone fractures and dislocation, warranting prompt revision surgery. By 2009, the FDA had received hundreds of such complaints. The failure rate had reached nearly 13 percent.
The DePuy Hip Recall Is Announced
In March 2010, the joint manufacturer alerted orthopedists of the problems associated with the ASR system. By that time, many surgeons had already identified them and stopped recommending the prosthesis to their patients. On August 26 of the same year, the DePuy hip recall was officially announced.
The company has indicated their willingness to “cover reasonable and customary costs of testing and treatment for patients who need services, including revision surgery.” But this assurance comes with conditions. The patient is required to sign a release form, and surrender their defective implant to the manufacturer. Also noteworthy, the company does not mention compensation for the suffering that recipients endured as the result of the failed devices.
Based on complaints from orthopedists and their patients, along with the timing of the DePuy hip replacement recall, evidence suggests the company was aware their hip replacement systems were flawed. Yet, they continued to sell them. If you received a DePuy hip implant, and are suffering from hip pain, joint loosening, difficulty walking, or other ASR side effects, learn more about your legal rights. Contact our DePuy hip replacement lawyers to discuss your legal options.