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ceramic, Chronic Pain, Cobalt chrome, FDA Hip Recall, Florida, Food & Drug Administration, Hip Pain, Hip Replacement, Incidence (epidemiology), New Jersey, Stryker, Stryker Trident Hip Replacement, surgery, Total Hip Replacement
Much Is Now Being Uncovered
The controversy surrounding Stryker’s Trident ceramic-on-ceramic line of hip implant products is only now making headlines. However, the problems associated with the Trident line have been plaguing patients for years and much is now being uncovered about the information that Stryker and other manufactures may have known about for years.
Who is Stryker?
The New Jersey manufacturer Howmedica Osteonics Corporation sells its hip implant system under the Stryker Trident Ceramic Acetabular System. Although there are other companies that market ceramic-on-ceramic hit implant products, Howmedica / Stryker seem to have the greatest market share. According to Douglass Kreis, a Florida attorney who has been following the Stryker controversy very closely, “Stryker brought ceramic-on-ceramic to the mainstream market. However, even accounting for the greater market share enjoyed by Stryker, we believe the audible sounds have much greater prevalence and purported incidence with Stryker’s product vis-à-vis the other companies’ who jumped onto the ceramic bandwagon.”
The FDA’s involvement
The Food and Drug Administration (FDA) inspected Stryker’s New Jersey plant in June and July of 2007. In various letters to the company, the FDA outlined some major concerns with Stryker’s manufacturing processes. Most of this wasn’t made public until the FDA wrote another letter to Stryker in November of 2007 (not made public until January of 2008) scolding the company for not addressing the deficiencies that the FDA had uncovered. According to Kreis, “Although much of that letter is redacted (edited), a reading between the lines is possible reflecting significant problems faced by Stryker.”
What Stryker should have known
Various studies, reports and medical conferences have exposed the problems being caused by ceramic-on-ceramic hip implants over the last few years. Prominent physicians such as Dr. Toni Aldo and Dr. Christopher Jarrett have reported on this issue, suggesting that companies like Stryker should have known what was going on. Kreis told us about another:
Though we believe that the defect was not necessarily in choosing ceramic-on-ceramic, there are material experts who believe that the use of two different materials is best for optimal function and longevity. These experts believe that you need to use two dissimilar substances, which will lend to greater compatibility and longer wear without the hard on hard abrading surface issues.
Incident rates are 10 – 20 times of what’s being reported
Kreis explains that, “although physicians are now saying that the incidence rate is anywhere between 5 and 10 percent, where the label indicated 0.5%, this means in reality that we are looking at 10 to 20 times the incidence rate than that which is actually warned of.” If you are experiencing problems with Stryker’s Trident PSL and Hemispherical Acetabular Cups, contact an experienced attorney who has been following this issue to discuss your situation. For a free, no-obligation consultation, please click here.
Technorati Tags: Chronic Pain, Cobalt Chrome, FDA Hip Recall, Hip Pain, Hip Replacement, Stryker, Total Hip Replacement, Stryker Trident Hip Replacement
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