Stryker Increases Quality Control Costs Following Hip Implant Problems
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.
4 comments
You can view warning letters sent by FDA to stryker using this search engine: http://www.fdable.com/warning_letters/query/618c5ede2fdc
May be of use for future suits.
I would like to know whom i contact about this lawsuite i believe my father in law developed mrsa from a complication of his hip replacement parts he felt like the thing slipped and withing 72 hours had mrsa and died within 72 more hours because of misdiagnosis but this started from his hip then went to hospitol misdiagnosis just trying to gain info anyone else contract mrsa?
On Oct 22, 2009 i received a total hip replacement here in New Orleans, The implant was manufactured by Stryker. Since that time i have had none stop pain and extreme difficulty walking. I was also hospitlized and in a coma on life support for 2 months with Staphylococcus Pneumonia in March of 2010. Also hospitalized with same strain of pneumonia in May and in Sept of 2010.
This Staphyloccus Bacteria has been found in the labs where Stryker developes it’s implants. The first episode of pneumonia almost took my life. What legal rights do i have, and where should i go from here?
My Mom had a total of 5 hip replacements… the last of which claimed her life. I know that the last three were revisions from the first previous two and that all the components were Stryker. The parts used from 2007 were recalled by the FDA in 2009 however, she was never notified by either Stryker or her surgeon and she even inquired. The surgery in May of 2012 resulted in a nasty case of MRSA and she battled it for 11 months all the while getting the run around from the surgeon and his PA\\\\\\\’s who dismissed her concerns that something was wrong telling her it was just scar tissue… finally in Jan of 2013 emergency surgery was done and they discovered the MRSA had reached the bone and the head and liner was again replaced.. she passed away Feb. 24, 2013.. I feel strongly that something must be done not only to the manufacturer but also to the surgeon and assistants who dismissed her concerns and the FDA for not doing their jobs and protecting people from the manufacturers and drug companies…