Stryker Rejuvenate Hip Recall Highlights Modular Neck Stem Problems

Following reports of problems that may be predictive of a trend, Stryker issued a recall last week for their Rejuvenate and ABG II modular-neck stems used during total hip replacements. This has raised serious concerns about the safety of modular hip replacements, which appear to cause problems similar to what has recently been associated with metal-on-metal hip replacements. 

The Stryker Rejuvenate Modular and ABG II modular-neck hip stem recall was announced by the manufacturer last week, indicating that the artificial hip component has been associated with fretting and corrosion of the modular neck junction, which could result in pain, swelling, local tissue reactions and early failure of the hip replacement.

Unlike most femoral components, which consist of one part, the modular femoral neck-stem involved in this recall features two metal parts that fit inside of each other.

Modular hip replacements are designed provide surgeons with an ability to better fit an individuals natural hip geometry in technically challenging situations, and they have been promoted as providing improved stability and range of motion, due to the custom fit. This has resulted in the modular hip replacements being used among many younger and more active patients.

The Stryker Rejuvenate Modular Hip System was just introduced in February 2009. While such implants are expected to last 15 to 20 years, the Stryker modular femoral neck stem is now being removed from the market less than two years later amid these problems.

The Stryker hip recall was issued after a clinical information report (PDF) by the manufacturer, which was released to highlight the benefits of modular neck stems, actually raised concerns about findings that individuals who received modular-neck femoral components may experience corrosion and wear of the component as the metal neck rubs against the metal stem.

As a result of the metal-on-metal contact present in the Stryker modular hip implant, metallic wear debris may be released into the body whenever motion is present. This can lead to elevated blood serum metal ion levels and metal hypersensitivity, which is known to cause local tissue reactions, premature failure of the devices due to osteolysis, loosening of the components and in some cases the development of pseudotumors. This may result in the need for revision surgery to remove and replace the implant.

Problems with Metal Hip Replacements

These modular neck hip issues are similar to recent problems with metal-on-metal hip replacements, where a metal head and metal cup come into direct contact. This may result in the same release of metallic wear debris, which has been linked to a thousands of premature failures, often resulting in risky hip revision surgery.

Over the past decade, metal-on-metal hip replacements grew quickly in popularity among surgeons, amid aggressive marketing by manufacturers, who suggested that they were stronger and more durable because of the all-metal design. However, concerns began to emerge among surgeons who noticed a higher-than-expected failure rate with the components.

In August 2010, media attention on the metal-on-metal hip replacement problems increased when a recall was issued for DePuy ASR hip implants. The manufacturer removed the DePuy ASR hips from the market after post-marketing data suggested that as many as one in eight may fail within five years. However, by the time the recall was issued, an estimated 93,000 DePuy ASR hips had already been implanted worldwide.

Since that time, thousands of individuals throughout the United States have filed a DePuy ASR hip replacement lawsuit alleging that the manufacturer negligently and recklessly promoted the metal-on-metal hip design without adequately testing the long-term outcomes or warning about the risks associated with metallic wear debris.

The manufacturers of other metal-on-metal implants also face similar lawsuits over their products, including the Wright Conserve hip, Biomet M2A-Magnum hip, DePuy Pinnacle hip and others.

Over the past two years, since information about the problems became more widely known, use of metal-on-metal hip replacements has fallen dramatically and some experts have called for a recall to be issued for the entire class of hip replacement systems.

Last month, the FDA held a two-day meeting involving a panel of independent experts who suggested that they see little, if any, benefit in using metal-on-metal hips, and urged all individuals who have already received one of the implants to obtain regular examinations to check on the condition of the hip, even if they are not experiencing problems. This may include annual x-rays and possibly blood tests to look for signs of metal blood poisoning.

Stryker Rejuvenate Hip Recall Lawsuits Likely On The Way

The recall is likely to lead to a number of Stryker Rejuvenate hip lawsuits brought on behalf of individuals who have experienced problems from metallic wear debris released from their modular neck stem, as well as potential class action lawsuits on behalf of individuals who are now at an increased risk of future problems.

Similar to what was seen after the DePuy ASR recall, some experts are suggested that the modular hip recall will draw the necessary attention to the problems with the design.

The Stryker Rejuvenate modular system was submitted for approval to the FDA as a substantially equivalent design to another modular hip system that was already on the market, the Wright Medical Profemur, which has also been associated with a number of problems.

According to 2009 data from an Australian hip registry, a Wright Profemur femoral stem was identified as having a higher-than-anticipated revision rate, with 11.2% of individuals who received the Wright Profemur Z stem requiring revision within three years.

Problems with the Wright Profemur hip design have been associated with reports of catastrophic failure, where the implant may fracture, break, degrade and ultimately fail.

Since 2010, a number of Wright Profemur hip replacement lawsuits have been filed on behalf of individuals who experienced problems with this implant as well.

According to information provided by Stryker following the recall, they indicate that the incidence of complications with their modular neck stems is “extremely low.” However, specific data has not yet been released about what the failure rate is or how many people may be expected to experience issues the longer they have the components.

Individuals who had a Stryker hip replacement with a Rejuvenate Modular or ABG II modular neck hip stem have been advised to contact their physician if they experience symptoms of pain or swelling around the replaced hip.