Investigation uncovers defects

The FDA’s investigation, conducted from June 1st through July 12th 2007, uncovered problems relating to Stryker’s Trident hip-replacement systems. According to the FDA, consumers have complained about the product’s defects and have had to undergo further surgeries. However, Stryker has done little to correct the problems. The FDA’s letter, dated November 28 2007, was only published on their website yesterday (see link below). According to the letter, Stryker received the following complaints:

• January of 2005 through May of 2007: Trident Hemispherical and Trident PSL cups failed to function; hip implant components have poor fixation. In some instances, these problems have required revision surgeries.
• January of 2005 through April of 2007: Squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments).
• January of 2005 through June of 2007: Improper seating of hip implants in broached bones resulting in bone fractures.

Stryker failed to correct problems

The FDA concluded that Stryker has “failed to implement adequate corrective and preventive actions (which would include verifying or validating the corrective and preventive action to ensure that such action is effective) in order to prevent the recurrence of nonconforming product and other quality problems.”

It warned the company that it must take “prompt action to correct the violations” addressed in its letter or it will take further action that may include “seizure, injunction and/or civil penalties.” Stryker has not posted a response to the FDA’s letter on its website (www.stryker.com).

To view the FDA’s letter, go to: www.fda.gov/foi/warning_letters/s6627c.htm. To discuss the issue with an attorney whose practice focuses in this area of the law, click here.