Zimmer Chooses Sales Suspension Over Hip Recall
The Zimmer Durom Cup artificial hip is a metal-on-metal implant, initially designed for stability and marketed to a younger population as a solution for those wanting to restore their active lifestyles. Shortly after it was introduced in the United States, however, patients and doctors started reporting Zimmer hip problems, with some filing a Zimmer hip lawsuit to regain money spent on expensive revision surgeries.
In response to the complaints about Zimmer Hip failure, the manufacturer temporarily pulled its Durom Cup from the market in 2008 to more closely examine the issues. This withdrawal has been mistaken by some to have been a Zimmer hip replacement recall, but in fact, such a dramatic measure was never taken. After a brief suspension of sales, the device was back on the market within a few months.
Zimmer hip replacement “recall” only temporary
The Zimmer Durom cup was first approved by the FDA in 2006, but by 2008, the FDA had received numerous reports of the device’s tendency to loosen and migrate. That year, one of Zimmer’s medical consultants, Dr. Larry Dorr—a highly experienced Los Angeles surgeon—warned the company of Zimmer hip problems. Dr. Dorr later wrote a letter to the American Association of Hip and Knee Surgeons, warning them of the high failure rate he was seeing with the device.
In response to all the negative publicity, Zimmer implemented what some called a temporary Zimmer hip replacement recall, or more accurately, a suspension of sales, in 2008 to further investigate the issues.
Zimmer hip problems blamed on surgical technique
For the next few months, Zimmer gathered information on the problems occurring with the Durom Cup. They were skeptical of any design flaws because the device seemed to be doing well in Europe. After reviewing a database of material from over 3,000 implant surgeries, they concluded there was nothing wrong with the technology, and the real issue was that American doctors had not received adequate training on how to perform the implant surgeries. Because the Durom was designed differently from other hip replacements, surgeons needed to be more precise in implantation.
After reaching this conclusion, the company developed a new method of teaching doctors how to perform the surgery, then again released the Durom Cup on the market. Doctors continued to disagree with the company’s findings, saying the problems were with the device itself, and the failure of the cup to fuse properly to the bone.
Zimmer hip lawsuits proceeding
Despite the temporary nature of what many call the Zimmer hip replacement recall, it still brought to light many Zimmer hip problems, some of which required Zimmer Hip revision surgery, after which more people came forward to file a Zimmer hip lawsuit. In 2010, a study from the University of Wisconsin found an over 11 percent failure rate with the Durom, again citing the lack of bony ingrowth to the back of the cup, which was supposed to secure it in place.
Zimmer has since set aside money to cover Zimmer hip lawsuits being filed by Zimmer Hip lawyers, which now claim not only early failure, but metal poisoning. In June 2009, the United States Judicial Panel on Multidistrict Litigation approved the centralization of federal Zimmer hip lawsuits in the District of New Jersey.