Stryker Corp. has indicated that at least $50 million more will be spent annually over the next three years on quality control systems designed to address manufacturing problems that impacted their Trident hip implant parts and surgical power tools, both of which were the subjects of recalls this year.
A Stryker Trident hip recall was issued in January 2008, for certain Trident Acetabular Cup and Trident Hemispherical Cup hip replacement components manufactured at Stryker’s plant in Ireland.
The hip implant parts were found to deviate from the manufacturing specifications, which potentially cause premature loosening of the parts, infection at the site of the hip replacement or other possible problems.
The problems with the Stryker Trident hip parts were discovered after the company received two warning letters from the FDA about manufacturing problems at their New Jersey plant. The FDA identified a number of violations of the Good Manufacturing Practice standards and a lack of quality controls at the Stryker plant.
According to a November 2007 letter sent to Stryker by the FDA, the company received numerous complaints about their Trident hip replacement parts between 2005 and 2007, yet they failed to adequately investigate or address the problems.
Stryker currently faces a number of hip replacement lawsuits from individuals who have developed problems with their components, such as squeaking of the hip implant or loosening of the parts. Some individuals are also investigating Stryker hip lawsuits as a result of staph infections which could be tied to the manufacturing issues and other quality control problems.
In September 2008, Stryker recalled approximately 26,000 of their System 6 surgical power tools and temporarily stopped production after discovering that the medical devices could develop a sticky trigger after a number of users.
During the company’s third-quarter earnings report last month, Stryker acknowledged that they will be spending at least $150 million over the next three year on quality systems throughout the corporation and all of their sites. They are also devoting resources to monitor quality data and adverse event reports to help them identify production problems earlier.