Stryker Hip Implant Injury - FDA Warning

The FDA is cracking down on a manufacturer of hip implants and hip and joint replacement parts. The FDA recently sent Stryker Corporation a six-page letter detailing the problems with the company's manufacturing process and other issues that need to be corrected immediately. There have been several problematic reports have surfaced in response to Stryker's hip implants.

Stryker Hip Implant Defects – What
you Need to Know

If you are one of thousands of people in the United
States who depends on a hip implant to get around and maintain your routine, you
need to take notice of the recent action taken by the US Food and Drug
Administration (FDA), as the government is in effect cracking down hard on one
of the leading manufacturers of hip implants and hip and joint replacement
parts. 

The FDA recently sent the manufacturer of the hip
implants in question, Stryker Corp. of Kalamazoo, Michigan, an extremely stern,
six-page letter detailing the problems that have been discovered with the
company’s manufacturing process and other issues that need to be corrected
immediately.  Below is a brief overview of this
issue.

The Problems
Discovered

Since 2005, several problematic reports have surfaced in
response to Stryker’s hip implants.  The first reports were generated by
patients who used them, as they reported such problems
as:

1.     
Extreme pain;

2.     
Difficulty walking;

3.     
Squeaky joints;

4.     
Fractured joint implants; and

5.     
Improper fitting of implants that led to bone
fractures.

 There were also FDA-generated reports of the presence of
disease-causing germs, known as Staphylococcus bacteria, in the company’s
manufacturing plant in New
Jersey after an inspection of the facility. 

 

The
Warning

In its letter, the FDA warned Stryker that the following
actions would be taken unilaterally if the problems with their products were not
immediately corrected:

1.     
Seize company property;

2.     
Levy fines;

3.     
Seek injunctions;

4.     
Refuse to approve the sale of new Stryker
products; and

5.     
Notify other government agencies about these
issues so it can be considered when awarding government
contracts.

 

The steps outlined in this warning letter are about as
stern as the FDA will get with a company short of a full-blown recall, and
should be taken very seriously by anyone who is considering a hip implant and
who hears the name ‘Stryker’ when deciding how to proceed with such a process
and approach to their need for relief.