A Look Back at Zimmer’s Suspension of Durom Cup Sales
The 2008 suspension of Zimmer Durom cup sales highlighted an issue within the federal government’s chief agency for regulating medical devices. The Duron Cup artificial hip joint received approval from the US Food and Drug Administration (FDA) through a shortcut process known as “510(k)”. With the prevalence of Zimmer hip failure claims and a sharp increase in the filing of Zimmer hip lawsuits, the approval process has come under sharp scrutiny.
Speedy process ignored Zimmer hip failure possibilities
The FDA’s 510(k) process allows a medical device to get a “fast-track” for approval if it resembles a similar device that had been previously approved. Since the Zimmer joint resembled older models, the FDA processed its approval through the 510(k) process, rather than rigorous testing that may have exposed the seemingly greater likelihood of premature hip failure. Many industry observers believe the process ultimately allows too many defective joints to reach the market.
Hip failure claims force Zimmer to investigate
In 2008, after prominent Zimmer consultant and orthopedic surgeon Dr. Dorr went public with his observations regarding the shortcomings of the Durom Cup specifically, the company issued a so-called “Zimmer hip recall.” For several months, the company voluntarily suspended sales of the Durom cup in order to investigate the validity Dr. Dorr’s claims. Ultimately, the company concluded that the devices were not in fact, defective. Instead, they redrafted the surgical instructions and released the product back on the market.
Claims of Zimmer hip failure resumed shortly thereafter. Without any validation from Zimmer, advocates began to look farther back at the origin of the problem. Perhaps, the FDA’s approval process is where the true root of the issue lies.
FDA requires post market study in lieu of Zimmer hip recall
The FDA has since required that the company submit post-market reports on the joint’s performance. Although much of the data has yet to be compiled, the significant number of Zimmer hip failure lawsuits tend to indicate that the implant has some severe problems. Medical documents exchanged throughout the discovery phase of the ongoing lawsuits could yield much relevant information as well. However, it may be some time yet before these cases reach trial.
High rates of Zimmer hip revision surgery
The high incidence of Zimmer hip failure has forced many patients to undergo revision surgery. This additional surgery is ordered to remove the defective joint and replace it with a new one. Often the surgery is the only option these patients have. Not only is the surgery more complicated to perform, the risks and rehabilitation are of greater magnitude and length as well.
Zimmer hip revision is costly, painful, and emotionally exhausting for patients who have already been through at least one surgery. A Zimmer hip lawsuit may not be for everyone, but a favorable result may the answer for many of these patients.
Meanwhile, the FDA 510(k) process is still in use today while critics continue to challenge the long-term good of a short-term policy.