More Trouble with Stryker Hip Products
This article covers problems with Stryker Corporation hip implants that led to the 2008 recall of the companys Trident PSL and Hemispherical Acetabular Cups models. For a discussion about Strykers 2012 hip implant recall, click here for an updated article.
Only one day after the Food and Drug Administration (FDA) released a letter scolding the Stryker Corporation for not correcting problems with its hip replacement products, the company has said that it is investigating another issue related to those products.
Wednesday, January 16th 2007
According to CNN (www.cnn.com), Stryker has said that it is investigating an issue with a socket portion of its hip replacement product known as Trident Acetabular Cups that were made in its County Cork, Ireland plant. Although the company has said that this issue is not a danger to patients or related to the problems addressed in Tuesdays press release from the FDA (see below), many are wondering whats going on.
Tuesday, January 15th 2007
The FDA released a letter sent to Stryker concerning an investigation it conducted at Strykers Mahwah New Jersey plant from June 1st through July 12th 2007. The investigation uncovered several issues relating to Strykers Trident hip-replacement systems.
According to the letter, there have been many complaints about the products defects that have resulted in patients having to have additional surgeries. The FDA blasted Stryker for not doing enough to fix the problems. Among some of the problems reported since January 2005 were:
- Improper seating of hip implants in broached bones resulting in bone fractures.
- Trident Hemispherical and Trident PSL cups failed to function; hip implant components have poor fixation. In some instances, these problems have required revision surgeries.
- 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).
Based on those findings, the FDA concluded that Stryker:
[F]ailed 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.
Based in Kalamazoo Michigan, Stryker is a global medical technology company who specializes in orthopedic products that are used in over 120 countries. The companys 2006 net adjusted earnings were $830 million. Their website is www.stryker.com.
As more information becomes known, patients with Stryker products may want to discuss the issue with an attorney whose practice focuses in this area of the law. For a free, no obligation consultation with a qualified attorney, please click here.
The FDAs letter to Stryker can be viewed at: www.fda.gov/foi/warning_letters/s6627c.htm.