FDA Ignores Deadline to Update Requirements for Class III Devices
Within a year after the Durom Cup was released onto the market in 2006, doctors and patients complained of Zimmer hip replacement problems. Even prominent surgeons reported issues with the device adhering to the bone, to the point where the company temporarily suspended sales in 2008 to investigate the complaints. This suspension has sometimes been labeled a Zimmer hip recall, but the company re-released the implant one month later.
Injured patients who have had to endure revision surgery don’t understand why the company didn’t do more clinical testing before putting the allegedly defective device on the market. Critics and surgeons, as well, have disapproved of the company and the FDA for allowing the Durom Cup to be implanted into patients without substantial testing beforehand.
The FDA was supposed to have come up with renewed guidelines concerning required testing for high-risk devices like the Zimmer Durom Cup by December 31, 2012, but they missed that deadline. It is now unclear when they may take steps to more effectively protect the public from potentially dangerous medical devices.
Zimmer hip replacement problems
Devices like the Zimmer Durom Cup are considered “Class III” in FDA terminology, which means they are supposed to go through a more rigorous premarket approval that includes clinical trials before being cleared for sale in the U.S. For many years, however, this hasn’t been the case.
The Medical Device Amendments of 1976 established the class system for medical devices, with Class III containing the most risky items. Congress always intended for Class III products to undergo clinical trials prior to FDA approval. They expected the FDA, however, to first determine which products were to remain in Class III and which could be moved down to the less risky Class II and Class I categories.
While waiting for the FDA to complete its task, even some Class III devices were allowed to gain approval through the less restrictive 510(k) process that only required the products prove their similarity to others already on the market, bypassing the clinical trial requirement.
Plaintiffs injured by Durom Cup claim tests were needed
Class III is the only product categorization that requires clinical testing. Such testing can extend the time it takes for companies to get new products to patients. Those products that are considered less risky, therefore, can better serve the public if allowed to go through the faster 510(k) approval process.
For the more risky Class III devices, however, the 510(k) process remains controversial. Devices like the Zimmer Durom Cup and the recalled DePuy ASR hip implant systems both gained approval through the 510(k). Plaintiffs who have filed a Zimmer hip lawsuit allege that clinical testing could have detected design defects that were later discovered through unnecessary patient suffering. Though no Zimmer hip class action lawsuit has been filed at this time, there are a large number of patients who were implanted with the device that have filed individual cases around the country.
FDA could determine future Zimmer hip recall
In 1990, Congress directed the FDA to establish a schedule to finish the transition to the more rigorous premarket approval process for all products that were to remain in Class III. The agency has still not completed this transition, which means that implants like the Zimmer Durom Cup are still allowed to reach patients without having to demonstrate effectiveness and safety in clinical studies.
According to a recent article in the New England Journal of Medicine (January 10, 2013), clearance of the DePuy ASR hip implant was based on some predicate devices that had poor clinical performance. Both the Zimmer Durom Cup and the ASR are metal-on-metal hip implants that have been linked with abnormally high levels of premature loosening and failure.
“As thousands of Americans are painfully learning,” said the authors, “there are unknown risks with devices that enter the market without clinical data showing safety and effectiveness, and implanted body parts cannot be recalled as easily as defective auto parts.”
In light of ongoing litigation regarding all-metal implants such as the Durom Cup, many consumers and physicians are wondering about the possibility of a future Zimmer hip recall.