Stryker Hip Replacement Systems - Problems Prompt Recall, Lawsuits

Stryker Hip Replacement Systems

Stryker Hip Replacement SystemsWhen Stryker Orthopaedics first launched the Rejuvenate and ABG II modular-neck Stryker hip replacements in 2008 and 2009, they didn’t expect to be facing the same claims of metal-on-metal hip complications as other manufacturers. Unlike the DePuy ASR or the Zimmer Durom Cup, which subject patients to potential metal contamination from components rubbing against one another, the Rejuvenate and ABG systems included a ceramic component and did not have a metal ball rubbing against a metal socket.

Post-marketing reports, however, indicated that the two-part hip stems, designed to give surgeons more options for the perfect fit, were shedding metallic debris into the body. The hip manufacturer implemented a Stryker Rejuvenate recall in July 2012, pulling both products from the market. This wasn’t Stryker’s first recall—in 2008, they withdrew two Trident ceramic hip implants following several reports of bone fractures and implant failures.

Today, Stryker is defending hundreds of hip lawsuits claiming the company failed to warn of the serious health risks, and failed to adequately test product performance before subjecting thousands of patients to serious and life-changing complications.

Stryker hip replacements problematic

Stryker received FDA approval to market the Trident ceramic-on-ceramic hip replacement system in 2003. In the first two years, however, the FDA received numerous adverse event reports related to hip implants made by Stryker. Patients claimed to be suffering from the following problems:

  • Difficulty walking
  • Pieces of the implants breaking off
  • Popping and squeaking noises coming from the Stryker hip replacements
  • Bone fractures
  • Inflammation and pain
  • Uneven bone wear

As the number of complaints continued to climb, the FDA responded by inspecting two of Stryker’s manufacturing plants. One of these was located in Mahwah, New Jersey, and the other in Cork, Ireland.

FDA cites contamination of Trident hip implants

After inspecting the hip manufacturing sites, the FDA sent Stryker two warning letters. The first was dated March 15, 2007, and cautioned that the Cork, Ireland facility was violating the Current Good Manufacturing Practices, with issues including adulterated manufacture, packaging, and storage of the Trident Stryker hip replacement components.

The second letter was dated November 28, 2007, and noted problems with New Jersey plant. The inspectors found staph bacteria clusters throughout the plant, and reprimanded Stryker for failing to find the cause of the contamination. The FDA also reprimanded the company for failing to address the numerous complaints about the Trident system, which involved poor adherence to the bone and improper implant seating.

On January 28, 2008, Stryker implemented a recall of two ceramic hip components manufactured at the Cork, Ireland facility: the Trident Hemispherical Cups and the Trident Acetabular PSL cup. The company did not admit to design defects, however, but stated only that the withdrawn products deviated from internal specifications. The recall affected thousands of Stryker hip implants across the country.

Plaintiffs file Stryker Trident lawsuits

As news spread about the problems with Trident hip implants, injured patients began to come forward to hold the company liable. As the number of Styker lawsuits continued to climb, the New Jersey Supreme Court centralized all cases filed in that state to one court in Atlantic County. Judge Carol E. Higbee is currently managing the proceedings there.

At the end of 2012, about 180 cases were pending in New Jersey, and so far, there have been no negotiated settlements. Patients have filed lawsuits in other states, as well. Miles Minkler filed in Oregon in May 2012, and seeks nearly $5 million in damages for injuries he suffered after being implanted with the Trident Stryker hip replacement. Minkler claims that after his hip replacement surgery, he suffered pain and discomfort in his right hip and groin, a popping and grinding of the right hip, a decreased ability to walk or otherwise move around, and the feeling that his right leg was “giving out.”

Rejuvenate and ABG II Stryker hip replacements

Stryker’s Rejuvenate and ABG II modular-neck hip implants received FDA approval in 2008 and 2009. The components were considered to be the latest advance in hip replacement technology. Stryker thought it was avoiding problems with metal-on-metal hip contamination by including ceramic cups and metal sockets. Meanwhile, the new two-part hip stems were designed to allow surgeons more flexibility in fitting the implant to the unique anatomy of various patients.

Unlike other hip implants that have a one-piece, fixed-length femoral stem, the Rejuvenate and ABG II modular-neck stems are made of two parts, creating the ability to adjust the length. The neck is inserted into the stem, and then the ball portion of the implant is placed on the end of the neck. The new design was intended not only to allow custom fitting, but to offer greater stability and minimal bone stress.

Both of these components, however, are made of metal. The initial reports from patients and doctors describing symptoms related to metal contamination were confusing, but it was soon discovered that the two stem components could wear against one another, causing small shards of cobalt and chromium to be deposited into the surrounding tissues.

Stryker Rejuvenate recall in 2012

In April 2012, Stryker issued an “Urgent Field Safety Notice” to distributors, hospital risk managers, and surgeons. The company indicated that patients were reporting metallosis from the two-part stem components. Such heavy metal contamination can lead to the following complications in patients:

  • Pain
  • allergic reactions
  • tissue damage and death
  • bone damage and loss
  • elevated blood levels of cobalt and chromium
  • formation of pseudo-tumors

In July 2012, Stryker announced the Stryker Rejuvenate recall, withdrawing both the Rejuvenate and ABG II modular-neck hip implants from the market. At the time, the FDA had received over 60 adverse event reports related to the implants and metal contamination.

On its website, the company admitted that the risks associated with the modular stems included “the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” Many patients who suffer from these complications have to go through risky revision surgery to have the hip implants replaced.

Why do patients file Stryker hip replacement lawsuits?

Patients who suffer complications from the devices file a Stryker  hip lawsuit to recover damages to cover medical expenses, physical therapy, lost wages, pain and suffering and other losses. Spouses may also claim loss of consortium. Stryker hip lawyers typically claim the company was negligent in making sure their products were safe before subjecting so many patients to elevated risks.

An Alabama woman, for example, filed a Rejuvenate lawsuit on November 1, 2012, in the Northern District of Alabama. She claimed that after being implanted with the Stryker hip replacement device, she experienced severe discomfort and had to go through revision surgery to have the device removed.

On December 6, 2012, Anthony Fletcher filed a legal complaint in San Francisco, California. He stated that he suffered extreme pain, discomfort, and the inability to walk after being implanted with the Rejuvenate hip system, and had to endure costly revision surgery to have the device removed.

Filing a Stryker hip replacement lawsuit

Patients who were implanted with a Stryker hip replacement such as the Trident, Rejuvenate, or ABG II modular-neck system, and who are experiencing complications like pain, immobility, swelling, weakness, or premature loosening or hip implant failure may be eligible for compensation. At present, Stryker hip attorneys are offering complimentary case evaluations to help patients determine their eligibility for filing a claim.

1. U.S. Food and Drug Administration. (2012, July 6). Stryker Initiates Voluntary Product Recall of Modular-Neck Stems Retrieved from http://www.fda.gov/Safety/Recalls/


2. Stryker Orthopaedics Modular Neck Stems Retrieved from http://www.aboutstryker.com/modularneckstems/