FDA Approval For The DePuy Pinnacle Hip Replacement System

As it was deemed safe to use, Johnson & Johnson's Depuy Pinnacle Hip Replacement System was given an by the Food and Drug Administration to be distributed in the public. It went through the process called 510 (k) device approval process wherein "a new model of a device be compared for safety and effectiveness with another lawfully marketed model. A successful 510(k) submission results in FDA permission to market the new device. The nature of this comparison depends on the device and the degree of risk associated with its use. The comparison may comprise physical or performance characteristics as measured by standardized methods." In short, for this device, Johnson & Johnson was given special clearance by the FDA to market the device without first determining the safety of the products. If you may remember, the recalled DePuy ASR Acetabular XL hip replacement system also went through the same process. Currently, Johnson & Johnson has an approved HIV medicine.

Despite the hip replacement issues they are currently facing, we can see that Johnson & Johnson is still thriving. Yet, the issue is still there. In fact, DePuy Pinnacle lawsuits are still being filed. The seriousness of the dangers imposed of this hip replacement device is quite blatant with this. As a matter of fact dangers such as implant loosening and metal toxicity are allegedly associated with DePuy Pinnacle hip replacement use. There is actually great irony about people reporting sufferings from using this device for less than a year because it is said to last for more than five years.

Since the Pinnacle device is quite similar with the recalled DePuy ASR Acetabular system, questions regarding the recalling of the pinnacle device arise. . For people affected with the dangers associated with the device, the DePuy Pinnacle hip replacement lawsuit is one of the immediate solution to the situation.