Stryker Hip Recall

Stryker Ortheopaedics is a worldwide leader in the medical device market and an industry-leading manufacturer of implants used in joint replacement and trauma surgeries. Over more than 75 years since the company’s founding in 1941, Stryker has helped thousands of patients to live fuller and more active lives after joint failure. Unfortunately, the company may also have harmed patients through the release of certain defective medical devices, which prompted a Stryker hip recall in both 2008 and again in 2012.

Although the two recalls removed dangerous hip replacement products from the market, thousands of patients had already been affected because the defective devices had been implanted during hip replacement procedures. Patients have begun taking legal action to hold the medical device manufacturers accountable through litigation.

Hip replacement products made by Stryker

Stryker is one of the leading innovators in the market for replacement hip joints and components.  In 2003, the company obtained FDA approval for the company’s Trident hip implant. Subsequently, in 2008 and 2009, the Rejuvenate and ABG II hip replacement systems were approved and released. The Trident model was made of ceramic components. The Rejuvenate and the ABG II were part of a class of metal-on-metal hip replacement products but were distinct in important ways from most hip replacement solutions on the market.

A hip replacement involves lining the acetabulum, which is a concave surface in the pelvis that the hip joint fits into. A rod is then inserted into the femur and a new femoral head put on top of the rod. This femoral head fits into the acetabulum and acts as the new hip joint.

The Stryker Rejuvenate and ABI II modular-neck systems were touted as being different than traditional replacement joints because the systems allow doctors to pick and choose from numerous options for a new two-piece neck and stem component.  Instead of just a one-size-fits-all stem to insert in the femur bone and one option for a replacement femoral head, patients could be fitted with a part that was appropriate for them.  The benefits of this, like the benefits of the Trident, were touted as increased flexibility and a longer-lasting hip replacement solution.

Unfortunately, minimal pre-market testing was performed to determine if the hip replacement products functioned as intended or were safe for human use.  The limited testing was made possible because the devices were brought to market under the FDA’s fast-track 510(k) clearance process.  The 510(k) clearance process allows for medical devices to be approved based on their substantial similarity to devices already on the market, without requiring extensive human testing to ensure safety.

Complications and problems associated with Stryker hips

Stryker’s Trident, Rejuvenate and ABG II systems all began showing signs of problems shortly after being released onto the marketplace, although it would take several years for the medical device manufacturer to institute a recall.

Complaints about the Trident hip surfaced as early as 2005 regarding:

• Popping and squeaking noises
• Problems walking
• Significant pain
• Broken bones
• Broken hip replacement components

For many patients, the only method of treatment for the side effects from the Trident was to remove the hip replacement product.

Although these reports continued between 2005 and 2007, Stryker took no affirmative measures to address them. The FDA cited the company’s failure to address problems in a warning communication in March of 2007 and again in November of 2007.

The March and November FDA complaints not only criticized the manufacturer for failing to  adequately address problems like broken bones, but also for failure to follow manufacturing best practices. The FDA was concerned that there were serious deficiencies in the manufacture, packing, storage and installation of the products in a Cork, Ireland facility and in a New Jersey facility.

In January of 2008, Stryker finally took action and recalled certain components the FDA had issued the alert about. The recalled components included the Trident Acetabular Cup System and the Trident Hemispherical Cup System. The components were both manufactured at the Cork Ireland facility that the FDA had expressed concerns about back in 2005.

Stryker Rejuvenate and ABG II Recall

The recall of the Trident products was not the end of the problems with all Stryker hip replacement models.  Both the Rejuvenate and ABG II modular-neck systems were released in 2008 and 2009 and were heavily marketed to a young and active audience between 2009 and 2012.  The metal-on-metal hip replacement products promised greater flexibility, more stability, less stress on the bone and a longer-lasting replacement joint.   By 2011, however, reports of complications with the Rejuvenate and ABG II were becoming increasingly common.

Recipients of the devices complained of:

• Dislocation
• Loosening of the hip implant
• Immobility
• Swelling
• Failure of the replacement joint

A February 2012 study published in the British Medical Journal also raised another concern, applicable not only to the Stryker products but also to the broader category of metal-on-metal hip products.  The BMJ article warned that the metal-on-metal components of all-metal hip replacement systems could rub against each other and result in metal ions breaking off into the blood and the area surrounding the joint.  The metal ions could cause metal alkalosis and muscle and bone could be destroyed by the ion build-up.

Several months later, in April of 2012, the company responded for the first time to serious concerns about the ABG II and Rejuvenate, sending an Urgent Safety alert to physicians.  The announcement warned of corrosion or “fretting” at the modular neck junction of the modular neck stem, which could cause Adverse Local Tissue Reaction (ATLR).

For many patients experiencing these complications, hip revision surgery was the only way to resolve the pain or reduce the serious health risks.  Though the April Urgent Safety Alert warned that a percentage of patients might be driven to repeated surgery due to tissue necrosis, metalosis or significant pain, the company still kept the products on the market.

It was not until July of 2012 that Stryker voluntarily recalled the Rejuvenate and ABG II systems, citing the need to study the risks of the hip replacement products.    In doing so, the company advised patients who had one of these hip replacement systems implanted to schedule a follow-up with the surgeon who performed the hip procedure so the surgeon could evaluate whether further medical action was necessary.

Patients can take legal action

Any patient who experiences serious complications, injury or loss related to these products may have the right to file a Stryker hip lawsuit.  Cases against  the manufacturer have been consolidated into multidistrict litigation (MDL) and plaintiffs may pursue claims in either federal or state court for damages related to the recalled medical devices. Stryker hip lawyers are currently offering complimentary consultations to injured hip recipients to determine if they have grounds for legal action.