Zimmer Hips—Complaints Surpassing Implants?

Grinnell, KSHip replacements are one of the most common procedures in the US and metal-on-metal (MoM) Zimmer hips are amongst the most widely used of hip implants. Zimmer Holdings also has a large share of complaints, according to the FDA, and with those complaints come Zimmer Hip lawsuits.

The New York Times (Aug 22, 2011) reported that MoM implants made up for nearly one-third of the estimated 250,000 replacements performed each year (estimates run as high as 500,000 patients having received MoM hips) and 1,600 Zimmer Durom Cup complaints were filed with the FDA from 2007 to June 2011. That amount is likely much greater because doctors and patients are not required to file adverse event reports—only companies must comply with regulators.

News of the FDA rules regarding sales of MoM devices come as a shock to Zimmer hip recipients, some of whom feel like "crash test dummies": no testing of metal-on-metal devices was required; no clinical trials were conducted. In fact, MoM recipients were the clinical trial. Now, the FDA appears to be frantically backtracking. In May 2011, the agency requested medical device producers, including Zimmer, to study how often their devices failed and to examine the threat to patients.

Countless Zimmer hip patients experienced severe pain, many have undergone painful revision surgery and a number of hip implant patients have been diagnosed with tissue damage and blood poisoning due to metallic debris caused by these allegedly defective metal devices.

Needless to say, Zimmer's MoM sales—both the Durom Cup and Zimmer Natural—are likely down (the NYT reports that current use of all metal devices has plummeted to about 5 percent of the market) and surgeons are looking at alternative materials, i.e., other than metal that can cause increased levels of cobalt and chromium in the bloodstream and other adverse events. (So are manufacturers: Zimmer recently introduced a hip ceramic-on-ceramic implant. According to the company news release, the Maxera Cup is designed for younger and active patients.)

While the FDA's move is a step in the right direction, it's too late for many people.

Mary has "double trouble." She had a Zimmer hip implant in 2004 and in 2007 another Zimmer hip. She didn't know they were Zimmer devices until her doctor called the hospital and confirmed they were both Durom cups. "I can't stand on my feet for more than 10 or 15 minutes," says Mary. "I have pain in my back on both sides, all the way down to my knees and I only have about 10 percent mobility—much worse than before these implants. I've been living with this pain since the first surgery."

"I'm worse off now than before I had this Zimmer hip," says Sasha. "There is some improvement in pain relief when I rest, but I cannot do the activities that I did before, and I'm very unhappy with the result of the surgery." Sasha's complaints are similar to those of Mary and others: pain and reduced mobility. They can't walk with any endurance, they have trouble going down stairs and both are facing revision surgery.

One more thing Mary and Sasha have in common: they have both filed lawsuits against Zimmer.