It has now been roughly a year and a half since the DePuy Acetabular Hip Replacement System (ASR Hip) was recalled. Our Chicago nursing home lawyers have frequently discussed the recall, which had affected many local residents-particularly seniors. However, there likely remains many community members who had hip replacement surgery with these one of these devices but remain unaware of the recall or whether or not their hip is defective. It is important for all those who may have been affected-and their family members-to understand the DePuy hip recall and its potential affect on their life.
The system in question includes “ball and cup” components to mimic the socket and ball of the femur in the human hip. Most hip replacements include both metal and plastic parts. However, the ASR Hip that was recalled was unique in that it puts a metal “ball” component in direct contact with a metal “cup.” This metal-on-metal contact may be at the heart of the problem with the medical device. These new hips achieved U.S. Food and Drug Administration approval to market the devices for use in 2005. They used a shortened approval system (501(k) process) to obtain FDA approval without having to undergo clinical trials.
It was not long after it entered use that reports came out regarding the failure of some of the hips; similar reports continued to build up over the coming months. Correction of the problem usually required the patient to undergo a painful and risky second surgery to replace the replacement. It wasn’t long before there were hundreds of reported case of early failure of the devices-usually caused by problems with the “cup” component of the device and metal-on-metal shavings being released inside the body. Reports appeared in newspapers about the problem as early as 2007, and the DePuy device manufacturers knew well before that of the reported issues with the devices. Yet, even after this time, patients were still given the device. Doctors investigating the evidence have explained that the company had significant data early on which indicated that these devices were failing at a far higher rate than other devices.
It wasn’t long before it became known that the DePuy hip defect was likely design-related. That it so say that it was not a problem with the actual manufacturing of the device but the whole idea of the device itself. Even the surgeon that designed the hip admitted in 2008 that the company knew that there were problems with the hip early on. Yet, despite this knowledge the company continued to sell the device-making more than $5.4 billion in 2009 alone on the product. It wasn’t until the summer of 2010 that the device was officially recalled by the FDA. Upon notice of the recall, the company admitted that a shocking 13% of all those who received the device may need revision surgery. This amounts to 10-15,000 patients.
Our Chicago DePuy hip lawyers encourage all local residents who have gotten hip replacements to ensure that this recall did not affect them. It is always better to error on the safe side and visit with a medical professional to confirm that additional steps are not needed to make sure that one is not in danger of having problems with the replacement. If you suspect that you or a loved one has been harmed by their replacement, please visit our office and share your story to learn about your legal rights.
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