Fda Approves Ceramic-on-metal Hip Replacement Systems After Years Of Clinical Tests
The United States Food and Drug Administration (FDA) has just approved the worlds first ceramic-on-metal hip replacement system on June 14, 2011. The ceramic-on-metal hip replacement system is the first to have a ceramic ball used with a metal hip socket to simulate natural movements; clinical tests have shown that this ceramic-on-metal system is just as stable as any of its predecessors.
The new ceramic-on-metal hip replacement system has been named The Pinnacle CoMplete Acetabular Hip System and is currently being manufactured by DePuy Orthopaedics Inc. According to DePuy it has been doing clinical tests on the Pinnacle CoMplete for the past two years to insure its stability and to avoid any adverse side effects the hip replacement system may have on its patients.
During the course of the two year clinical trial the control group of 196 people where given the traditional metal-on-metal hip replacement systems, while the experimental group of 194 people were given the new ceramic-on-metal hip replacement systems. The test results showed a positive one for DePuy people who need a second surgery where nearly identical between the control and experimental group. The results that were given by DePuy showed that in the control group 3 people needed a second surgery while only 2 people needed a second surgery in the experimental group.
Based on these results the FDA the was able to give approval of the Pinnacle CoMplete on the condition that DePuy conduct post-market studies and monitor the patients receiving the new system for adverse events and metal ion concentrations in their blood. Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health had this to say about the Pinnacle CoMplete; "Orthopedic surgeons and their patients now have an additional option for total hip replacement."
Time will tell if the new ceramic-on-metal hip replacement systems will replace its predecessor the metal-on-metal hip replacement system, as many have already been injured by the older type of metal-on-metal hip replacement systems. Those injured as well as many others have begun to call for a DePuy Pinnacle Recall. For more information and possible a free consultation feel free to visit a DePuy Pinnacle lawyer as soon as possible.
The new ceramic-on-metal hip replacement system has been named The Pinnacle CoMplete Acetabular Hip System and is currently being manufactured by DePuy Orthopaedics Inc. According to DePuy it has been doing clinical tests on the Pinnacle CoMplete for the past two years to insure its stability and to avoid any adverse side effects the hip replacement system may have on its patients.
During the course of the two year clinical trial the control group of 196 people where given the traditional metal-on-metal hip replacement systems, while the experimental group of 194 people were given the new ceramic-on-metal hip replacement systems. The test results showed a positive one for DePuy people who need a second surgery where nearly identical between the control and experimental group. The results that were given by DePuy showed that in the control group 3 people needed a second surgery while only 2 people needed a second surgery in the experimental group.
Based on these results the FDA the was able to give approval of the Pinnacle CoMplete on the condition that DePuy conduct post-market studies and monitor the patients receiving the new system for adverse events and metal ion concentrations in their blood. Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health had this to say about the Pinnacle CoMplete; "Orthopedic surgeons and their patients now have an additional option for total hip replacement."
Time will tell if the new ceramic-on-metal hip replacement systems will replace its predecessor the metal-on-metal hip replacement system, as many have already been injured by the older type of metal-on-metal hip replacement systems. Those injured as well as many others have begun to call for a DePuy Pinnacle Recall. For more information and possible a free consultation feel free to visit a DePuy Pinnacle lawyer as soon as possible.
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