Hip Replacement Recall

Several hip replacement recalls have been issued with regard to various hip joint replacement systems and resurfacing devices.  Most of the systems that have been recalled fall are considered metal-on-metal hip implants. Metal-on-metal hip implants were originally marketed as a superior alternative to a traditional hip replacement or hip resurfacing system because metal components were touted to last longer than its competitors using other materials. Some manufacturers went so far as to claim that their systems could provide greater flexibility and a wider range of motion.

Unfortunately, these implants began exhibiting high failure rates due to the break down of metal inside the body.  A wave of complaints and a series of personal injury lawsuits finally prompted both the companies as well as the FDA to issue hip recalls of some of the most popular systems on the market.

Hip replacement recalls prompted by failing devices

Hip replacement surgeries have been performed for decades, with the procedure dating back to the 1940’s.  When a patient undergoes a hip replacement, a lining is placed within a concave area in the pelvis known as the acetabulum. The lining is often called the acetabular cup.  In a complete hip replacement, a stem is also placed within the femur, topped with a femoral head that fits within the hip socket.  While the stem and femoral head were traditionally made with ceramic components, metal-on-metal hip implant systems use a metal acetabular cup, a metal stem and a metal femoral head.

Hip resurfacing is a less invasive alternative, but metal parts were also developed for this method of resolving hip joint problems. In a resurfacing, only the femoral head and the acetabular cup surfaces are involved.

The metal components used in hip implants are typically made of a mix of chromium and cobalt, and resurfacing is considered less invasive than total hip replacement. Though both procedures are meant as a long-lasting solution to chronic hip pain,patients began coming forward at a significant rate complaining of:

• Loosening of the components
• Infection
• Decreased range of motion and reduced mobility
• Broken bones and fractures
• Metallosis (the buildup of metal ions in the body)
• Inflammation
• Injury to the muscles
• Nerve damage
• Popping, crunching or other noises from the hip caused by movement
• Severe pain

Complaints related to these complications prompted further investigations and subsequent FDA warnings about the dangers of hip replacement components, particularly metal-on-metal ones. A few of those models under the most scrutiny were eventually removed from the marketplace altogether.

Models subject to hip recalls

Hip replacement recalls are not limited to just one brand or one type of metal-on-metal hip implant.

Several recalls have been announced including:

• DePuy ASR Hip Recall: DePuy Orthopaedics recalled the Articular Surface Replacement (ASR) Acetabular Hip System on August 24, 2010. Also recalled was the ASR Hip Resurfacing System, which was not ever cleared for use in the U.S. although some patients have parts from this system or had the system implanted during clinical trials or while abroad. By the time of the DePuy hip recall, approximately 93,000 people worldwide already had a DePuy hip implant. Unfortunately, studies have indicated that around 40 percent of patients will experience a failure of their ASR device within five years and the failure rate will only increase over time.  Evidence from a 2013 lawsuit indicates that executives at DePuy may have known as early as 2008 that the medical device was defective and yet failed to alert the public to the dangers.
• Stryker Rejuvenate Recalls: Stryker’s Rejuvenate and ABG II were the subject of a safety communication sent to hospitals, patients and surgeons in April of 2012 and were subject to a voluntary recall on July 6, 2012. The Stryker hip recall was prompted by concerns that the metal would corrode and that cobalt and chromium from the femoral head and stem would cause metallosis and adverse tissue reactions. 

Zimmer Inc., another manufacturer, was also forced to temporarily stop sales of the company’s Durom Cup amid concern that there was a high need for revision surgery in procedures where the device was used.  However within just three months, Zimmer re-released the product again insisting that surgical technique, and not a failure of the medical device, was the cause of the problems in question.

Other models that have been recalled or removed from the market include:

• Wright Medical’s Conserve Plus and Profemur Z Hip Stem
• Opteon (Exactech)
• Smith and Nephew R3 Acetabular metal liner

Fast-track 510(k) clearance process

It may seem hard to believe that a medical device with such a high failure rate could make it to the market, but the reality is that many of the metal-on-metal hip implant systems were never tested or did not undergo extensive testing before their release. This is because the devices made their way to consumers via the FDA 510(K) clearance process.

The 510(k) clearance rules allow for the fast-tracked release of medical devices as long as substantially similar devices are already widely available.  Since so many similar products are already being sold, manufacturers who produce metal-on-metal and other hip devices are able to take advantage of the lax regulation and offer largely untested hip implants for sale.

Many of the most recently recalled devices, including the DePuy ASR Acetabular Hip System and the Stryker ABG II both were cleared in this manner, and both turned out to suffer design flaws.

Hip replacement recalls trigger litigation

Unfortunately, it is the patients who suffer when medical devices are not properly tested and recalls become necessary. An experienced hip recall lawyer can help injured victims hold device manufacturers accountable, but there are specific legal steps a victim will need to take to obtain monetary damages for pain and suffering, medical costs, lost income and other damage caused by metal-on-metal hip products. 

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