Zimmer Prepares for Metal-on-Metal Hip Replacement Lawsuits

Shortly after Zimmer introduced the Durom Cup in the United States, concerns emerged about a high number of Zimmer hip replacement recall involving the hip implant, where the component loosened and required revision surgery.In July 2008, Zimmer suspended US sales of the Durom Cup following complaints about Zimmer hip implant failure due to loosened components that required revision surgery. Approximately 12,000 individuals had the Zimmer Durom Cup system implanted in their hip between 2006 and 2008. While Zimmer’s own estimates in 2008 suggested that some doctors have experienced failure rates as high as 5.7%, more recent claims made in Zimmer Durom Cup lawsuits suggest that the artificial hip failure rate is between 20% and 30%.

In April 2008, prominent Los Angeles orthopedic surgeon, Dr. Larry Dorr, notified members of theAmerican Association of Hip and Knee Surgeons about the Zimmer Durom Cup problems he was encountering with patients who received the component.  Problems such as loosing of the components and a higher than expected rate of Zimmer hip revision surgery were identified by Dr. Dorr.After initially dismissing Dr. Dorr’s report of problems, Zimmer agreed to initiate an investigation of the Durom Cup problems in May 2008. 
After reviewing data from over 3,100 cases, Zimmer concluded that the technology and design parameters of the Durom Cup require a higher degree of precision than was common in hip replacement surgical techniques in the United States and that additional instructions and training should be provided to doctors before the devices are implanted.

Zimmer Holdings, Inc. reported in July that it is setting aside $75 million to resolve current and future lawsuits over their Durom Cup hip replacement system. The medical device company announced the set aside in its 2010 second quarter financial report, saying that it is to address known and anticipated claims connected to its decision to suspend marketing and sales of the Durom Cup for a time 2008 due to unexpectedly high failure rates. Sales resumed several months later after Zimmer improved the warnings and instructions that accompany the device.Earlier this year, the U.S. Food & Drug Administration (FDA) asked DePuy Orthopedics, Zimmer and 19 other manufacturers of metal-on-metal hip implants to conduct safety studies aimed at determining if these devices are shedding dangerous amounts of metallic debris in patients.