Stryker Rejuvenate and ABG II

Stryker Rejuvenate and ABG II Recall

Hip replacement patients who thought they were safe from metal toxicity may still be at risk if they received one of the two Stryker hip components included in a nationwide recall on July 4, 2012. Many will need revision surgery to remove the implants due to associated problems, which include the potential for metallosis. Patients who received a Stryker hip implant should consult their physician and may be eligible to bring a legal claim.

Many patients could still be unaware of the recall status of their hip. The recalled devices include (1) Stryker Rejuvenate modular stems and (2) Stryker ABG II Modular stems. These components were introduced amidst the movement away from “metal-on-metal” hips, which gained momentum following the DePuy ASR recall in 2010. Because the recalled Stryker implants did not have metal-on-metal articulation at the site of the cup, they were considered a safe alternative.

 

What was the Reason for the Recall?

The irony is overwhelmingly frustrating for those who were aware of the dangers associated with metal-on-metal hips when they agreed to proceed with the Stryker ABG II or Rejuvenate stems. Metal-on-metal hips had gained so much negative publicity that many were relieved they didn’t have to worry about metal toxicity with these implants. The Stryker Rejuvenate and ABG II are two types of modular hip replacement systems. A modular hip replacement system consists of several interchangeable components. The components come in various sizes, making it easier for surgeons to create a custom fit hip replacement. Stryker had touted the devices’ ability to contour to the natural biomechanics of the body, so many patients were easily sold on the system. 

The Stryker Rejuvenate and ABG II were components of implants that were considered a safe alternative to metal-on-metal hips, because the articulation at the site of the cup was not “metal-on-metal.” The movement away from metal-on-metal hip components, which was largely a product of the DePuy ASR metal-on-metal hip recall, was due to the potential problems caused when two metal surfaces rub together.

However, these Stryker Hips followed a relatively new concept of making the stem and neck separate and interchangeable pieces instead of one comprehensive unit. Thus, these implants had an additional point where two surfaces rubbed together. Both surfaces were metal.

So, even though by traditional definition the Stryker Hips were not “metal-on-metal,” the potential for the same problems has been discovered. In 2016, experts estimate the device has failed at the neck-stem interface at a 60% rate.

Symptoms of Failing Stryker Rejuvenate and ABG II Hips

The main concern with the Stryker ABG II and Rejuvenate hips is the fretting and corrosion of the stem and neck joint, which can cause elevated levels of chromium and cobalt in the bloodstream (metallosis). This can lead to the following complications:

  • Pain/limited mobility
  • Tissue inflammation/swelling
  • Formation of tumors or pseudo-tumors
  • Bone loss or dissolution
  • Tissue death (necrosis)
  • Need for revision surgery

The 501(k) Approval Process

Stryker Rejuvenate and ABG II modular stems were approved in 2008 through the FDA’s 510(k) clearance track, meaning Stryker was able to prove that the devices were substantially equivalent to an existing device. This allows manufacturers to skip the in-depth testing that the FDA requires of new devices. The DePuy ASR, Pinnacle and many other metal-on-metal hips were approved through the same process.

The device that was compared to these products these products in the 510(k) approval process (“predicate device”) was Wright Medical’s Profemur stem, which has a similar “modular” stem design.

How do I Know if I Have a Recalled Stryker Hip Device?

The FDA approved the products through the 510 (k) process in 2008 and were implanted as early as 2009. The products were taken off of the market in summer 2012. If your surgery did not fall between those two dates, it does not necessarily mean you do not have a claim. We recommend you find out what type of implant you have no matter what. We can then evaluate whether your case meets our criteria for success.

Litigation

The Judicial Panel on Multidistrict Litigation (JPML) made the decision to transfer all federal claims against Stryker for their Rejuvenate and ABG II devices to Minnesota before Judge Donovan W. Frank.  Another consolidated state court action in New Jersey was also generated regarding the Stryker Rejuvenate and ABG II recall. The New Jersey state court judge ordered a staged mediation program that assisted the parties in identifying parameters for a potential global settlement. No case was ever tried in this litigation. 

Requests made by Stryker that this MDL only include Stryker Rejuvenate devices and be renamed “Rejuvenate Total Hip System Products Liability Litigation” were denied by the Panel. Thus, the litigation involved  both Stryker ABG II and Rejuvenate devices.

This was the first major metal-on-metal hip litigation generated for a non-acetabular metal-on-metal failure.

Judge Holding Documents

What is a multidistrict litigation?

A multidistrict litigation (MDL) is a consolidated action in federal court. It is important to make the distinction between an MDL and a class action litigation:

  • In class actions, one representative lawsuit is filed by one or more plaintiffs on behalf of many other claimants. Compensation is often divided equally. This is why class actions are generally inappropriate for claims involving injuries (such as hip device failures).
  • In a multidistrict litigation, individual cases are consolidated in one district of the United States and under one judge for pre-trial proceedings such as discovery and causation. This includes things like document review, depositions, and development of expert witness reports. In the end, each claim remains individual and is awarded compensation based on its individual damages and merits.

Settlement

On November 3, 2014, courts announced a national settlement was reached in the Stryker Rejuvenate/ABG II Hip Replacement Lawsuits. Individuals that have had the Stryker Rejuvenate or ABG II device implanted and then revised (surgically removed) by November 3, 2014 for reasons of documented device failure are eligible to participate in the Stryker Hip Settlement.

It is estimated that the Stryker Hip Settlement will pay in excess of $1 billion to qualifying individuals under the settlement. Approved participants are entitled to a base payment up to $300,000, subject to certain deductions including for age and previous artificial hip implants. Furthermore, the settlement provides for certain additional payments on top of the base award for those who have experienced settlement delineated, extraordinary injuries in addition to the revision surgery and recovery.

An unprecedented provision of the settlement sets no cap on the amount Stryker will be required to pay to reimburse injured, qualifying participants.

There are still many individuals who experienced failure of this device after 2014. This litigation is ongoing for those individuals.

A second settlement was reached on December 19, 2016. The settlement is applicable to any patient with a Rejuvenate or ABGII device that has had revision surgery before December 19, 2016.