Stryker Hip Replacement Problems - Recall, Failure Rates and Lawsuits

Women More Likely to Suffer Hip Replacement Problems

Staff Writer | February 26th, 2013

Stryker Hip Replacement ProblemsOn February 18, 2013, the JAMA Internal Medicine medical journal published a study showing that women are nearly 30% more likely than men to experience total hip replacement failure. In other words, female patients who undergo a total hip replacement, or hip arthroplasty, are more likely to experience Stryker hip replacement problems and, eventually, implant failure.

Women may be at higher risk for Stryker hip replacement problems

The FDA-funded prospective cohort study detailed information from more than 35,000 patients. Each had undergone a total hip replacement at one of 46 hospitals within the Kaiser Permanente health system. Among the most startling findings was that women had a 29% higher rate of implant failure. Other notable differences between men’s and women’s implants include the fact that women’s implants used smaller femoral heads, and were more likely to be metal-on-polyethylene (not metal-on-metal) implants. As Stryker’s Trident and Rejuvenate implants both include metal and ceramic components, it may be true that women are at a higher risk of Stryker hip replacement problems.

The study did not reach a conclusion on why women experience higher failure rates than do men. Nevertheless, researchers did conclude that this evidence makes it clear that gender should be an important factor in determining recommended implants, device innovation, and patient management.

Metal-on-metal implants linked to serious health concerns

The study’s results are very timely, as hip implants – and particularly metal-on-metal implants – are under the microscope. These implants have been linked to early failure rates, often due to premature implant loosening. Additionally, metal-on-metal implants may created friction between component parts, causing metal to flake off and enters the bloodstream. The resulting condition is known as metallosis, or heavy metal poisoning, and may cause severe tissue death, bone damage, and other serious health problems.

In January 2013, the FDA released new guidelines for metal-on-metal hip implants. The federal regulatory agency counseled doctors to only use metal-on-metal hip implants if other hip replacements were insufficient or inappropriate for a patient’s needs. The FDA asked manufacturers to undergo necessary testing and other measures to prove that their implants are safe enough to remain on the U.S. market. The agency also announced that all future metal-on-metal hip designs will be required to undergo extensive clinical trial testing before receiving approval.

Stryker hip replacement recall affects two devices

Though Stryker’s problematic hip implants – known as the Trident and Rejuvenate hip replacements – are not metal-on-metal, they have received many complaints from injured patients. Among reported Stryker hip problems, consumers report:

  • Difficulty walking
  • Implant breaking into pieces
  • Popping and squeaking during movement
  • Bone fractures
  • Inflammation and pain
  • Uneven bone wear

The volume of complaints resulted in the 2008 and 2012 Stryker hip replacement recall, which withdrew from the market the Trident and Rejuvenate implants, respectively. Nevertheless, many patients had already been injured from their implants. Many filed Stryker hip lawsuits to recover damages from their injuries.

  1. JAMA Internal Medicine Report on Implant Failure.

  2. Doctors Given Millions by Device Makers Fail to Disclose Pay in Research.