Zimmer Holdings initiated a brief U.S. recall of the Durom Cup hip in July 2008. Patients complain about device failures resulting from loosened components.
Since Zimmer released its Durom Cup hip implant – also known as the Durom Acetabular Component – in 2006, tens of thousands of Americans received one. But after only two years on the market, the device maker suspended its sales because of mounting complaints from patients and doctors about the artificial hip failing prematurely.
The company elected not to recall the hip, however, and it told surgeons not to return unused Zimmer hip implants, despite the above-average rate of revision surgery. A few months after halting the sales of the device, Zimmer returned it to the market and started selling it again.
Why the change of strategy? Zimmer suspended sales “because the instructions for use/surgical technique instructions were inadequate.” Any failures or other complications resulted from product defects.
The company released new surgical instructions, and officials said the device would remain available in the United States.
What Zimmer would not do, the U.S. Food and Drug Administration did do. The FDA issued a class II recall in the fall of 2008 for more than 19,000 U.S. devices. The agency said the hip was misbranded, calling its labeling “false and misleading.” Regardless, Zimmer continued to sell the implant.
The Durom Cup was designed to fuse to the hip socket without cement or screws by encouraging bone to grow into the cup and hold it in place. In some patients the implant loosens prematurely, causing pain, swelling and a number of other complications. Because it is a metal implant, the implant can also generate high levels of metal in the body, leading to damaged tissue and bone.
People who experienced these life-changing side effects, bolstered by the FDA’s recall, filed produce liability lawsuits against Zimmer. Among other things, most of the claims call the device’s design defective.
Temporary Suspension of the Durom Cup
Zimmer investigated suspected issues in the Durom Cup and advised U.S. surgeons to stop implanting the hip model. It also suspended sales temporarily and said it would could re-label the hip and provide additional training to orthopaedic surgeons on the proper positioning and installation of the device. The suspension lasted two months, from July until August 2008, during which time the device remained for sale in non-U.S. markets.
In a statement, the company said it “has found no evidence of a defect in the materials, manufacture, or design of the implant.”
Injured patients filed lawsuits that state the company did not disclose the true failure rate of the device to doctors or the public and also failed to issue a proper recall on the product.
Above Average Failure Rates
According to The New York Times, “Zimmer data and interviews with doctors suggest that hundreds of patients might need [revision surgery] in the coming years.”
Doctors expect 1 percent of implants to fail in about a year and 5 percent in five years, but a 2011 review revealed the Durom Cup had a revision rate as high as 15 percent. A 2010 study by Berton et al stated that the implant’s design caused it to have a “low survival rate at five years.”
Some lawsuits estimate the failure rate may be as high as 30 percent.
Dr. Lawrence Dorr, a highly experienced surgeon and consultant for the manufacturer, first brought the failures to the company’s attention after a number of his patients required revision surgery in 2007. The doctor stopped using the device and notified the FDA. He publicly warned other surgeons on April 2008.
|Dr. Dorr wrote to fellow doctors:|
|Revisions were performed because the patients exhibited classic signs of a loose implant even if X-rays did not show problems.|
|The fixation surface on the Durom Cup was not adequate.|
|Implantation technique was not the problem, implant design was.|
Durom Cup Lawsuits
According to Durom Cup lawsuits filed in court, the implant’s design is faulty because it does not function as intended. Because it is a metal-on-metal implant, it releases metal particles into the blood and surrounding tissues, causing metal poisoning and bone and tissue death.
Complaints also state that Zimmer knew about the implant’s defects and continued to market and profit from the product.
Walter Thomas was forced to have revision surgery only two years after he received his Durom Cup when the implant failed. He endured pain and disability. Even after his doctor replaced the implant, Thomas still suffered from problems. The extensive bone and tissue death made it difficult to implant another device.
A number of lawsuits are pending in federal court in New Jersey and several more in state courts.