Zimmer Hip Replacement Recall

zimmer hip recallThe Zimmer hip replacement recall is an issue which has affected the lives of many hip replacement patients. Zimmer Incorporated is a company that specializes in designing joint replacement technologies. Zimmer has designed a number of hip replacement prosthesis. While some of Zimmer’s products have been successful, others have a troubled track record. Specifically, Zimmer’s Durom Cup hip replacement product led to the Zimmer hip replacement recall.

Durom Cup Side Effects

The Durom Cup is a hip replacement product which the FDA approved for use in 2006. It is used in total hip replacement operations, where a significant amount of bone is removed from the hip socket, and “ball” at the top of the femur, and is replaced with artificial materials. The Durom Cup is constructed out of metal and is used in a metal-on-metal joint system. This all-metal hip replacement system was constructed in an effort to increase the lifespan and flexibility of artificial hips. However, for many patients who had a Durom Cup installed in their hip, there have been more side effects from the all-metal Durom Cup than benefits.

The Zimmer hip replacement recall came about as a result of the serious side effects which can accompany installation of a Durom Cup. These side effects generally begin approximately a year after hip replacement. The first side effects of a faulty Durom Cup tend to be increasing stiffness in the hip. This stiffness is often accompanied by strong pain. Over time, this pain and stiffness can worsen to the point where mobility is significantly compromised.

Zimmer Hip Recall History

The troubling side effects of the Durom cup were first brought to the medical community’s attention by the orthopedic surgeon Larry Dorr in April of 2008. In a letter to the American Association of Hip and Knee Surgeons, Dorr made note of the high failure rates he was experiencing with the Durom Cup. Dorr reported that of 165 hip replacement surgeries he had performed using the Durom Cup, 14 had necessitated a revisionary surgery to replace the cup.

In Dr. Larry Dorr’s opinion, the failure of the Durom Cup in replacement hips was a result of faulty construction. In his opinion, as well as that of many other orthopedic specialists, the Durom Cup did not seal correctly in the hip socket. As a result, it often came detached from the hip socket of patients within the first few years of replacement surgery. Often this detachment proved very painful and immobilizing for patients. Once detached, the metal apparatus of the Durom Cup could move around and rub on the bone of the hip socket, causing agonizing pain.

Zimmer Hip Replacement Recall

In 2007, Dr. Larry Dorr contacted both the FDA and Zimmer Incorporated in order to warn them of the problems associated with the Durom Cup. The response from Zimmer was that the failed Durom hip replacements were a result of improper installation by surgeons, not because of improper design by Zimmer.

The Zimmer hip replacement recall began in July of 2008. The Zimmer hip replacement recall ended in August of 2008. During the Zimmer hip replacement recall, Zimmer stated that they were voluntarily removing the Durom Cup from the market in order to update the labeling of the product and supply additional installation training to surgeons. However, many orthopedic surgeons believe that the failings of the Durom Cup are actually a result of flaws in the cup’s design, not inadequate surgical technique. In the aftermath of the Zimmer hip replacement recall, a number of lawsuits have been filed by patients against Zimmer.

Lawsuits Following Zimmer Hip Replacement Recall

Zimmer has been sued by many patients following the Zimmer hip replacement recall. Zimmer has set up a $69 million fund to compensate patients who have suffered damages as a result of faulty Durom Cup hip installations. Despite the Zimmer hip replacement recall and attendant lawsuits, Zimmer maintains that the problems with the Durom Cup are a result of inadequate surgical technique, not design.

View Sources
  1. "Background on Durom Cup Status." Zimmer.com. Zimmer, 22 07 2008. Web. 2 May 2013. http://www.zimmer.com/web/enUS/pdf/Durom_Backgrounder_on_Status_7-22-08.pdf
  2. Blanchard, Cheryl. "Urgent Device Correction." Zimmer.com. Zimmer, 22 07 2008. Web. 2 May 2013. http://www.zimmer.com/content/pdf/en-US/DUROM-SURGEON-LETTER-07-22-08.pdf
  3. Meier, Barry. "Senator Seeks Data on Artificial Hips and Knees." New York Times 30 7 2010, B2. Web. 3 May. 2013. http://www.nytimes.com/2010/07/31/health/31device.html?_r=0