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andomized clinical trial, ceramic, Ceramic on metal hip, Clinical trial, DePuy, FDA, FDA approval, Food & Drug Administration, Hip Replacement, metal, metal components, Orthopedic surgery, Pinnacle CoMplete Acetabular Hip System, polyethylene liner, second surgery, surgery, Total Hip Replacement
First Ceramic-on-Metal Total Hip Replacement System Approved
June 14, 2011 — The US Food and Drug Administration (FDA) has approved the first ceramic-on-metal total artificial hip system for patients with osteoarthritis.
Previous total hip replacement systems cleared or approved by the FDA have used different combinations of metal, ceramic, and polyethylene (a form of plastic). The Pinnacle CoMplete Acetabular Hip System (DePuy Orthopaedics Inc) is the first to combine a ceramic ball and a metal socket.
“Orthopedic surgeons and their patients now have an additional option for total hip replacement,” Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said today in a news release.
Yesterday’s approval was based on a 2-year, randomized clinical trial that found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received a metal-on-metal hip implant. Two patients who received the ceramic-on-metal system required a second surgery to replace their new implant compared with 3 patients who required a second surgery in the control group.
As a condition of approval, the manufacturer will conduct a postmarketing study, monitoring patients receiving the new system for adverse events and metal ion concentrations in their blood.
Technorati Tags: arthritis, Articulating Joints, Baby Boomers, ceramic, Elderly Patients, hip implant, hip prosthesis, Hip recall, Hip Replacement, Hip Revision, joint disease, joint replacement, MoM hips, orthopaedic implants, polyethylene wear debris, polymeric, ceramic-on-metal hip, FDA, FDA Appproval, Clinical Trials, second surgery, metal ion concentrations
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Earl's View 
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I was under the impression I was given ceramic/metal hip replacements in the UK in 1999. The reason was of my young age at the time, 36.
Can this this be correct as I’ve been suffering severe poisoning type symptoms for many years & when I exercise I have a metallic taste in my mouth along with liver, pancreas, chest, left hip/thigh/buttock & kidney pain at the same time. Really need some help as I seriously think whatever is happening is going to cause a heart attack.
It sounds like metal ion poisoning to me. You definitely need to get cobalt and chromium blood tests.
Earl
Thanks for your reply I will speak to my GP about getting tested.
Can I just ask you, as I now have the description of my surgery from my medical notes & it was described as a “ceramic modular bi-lateral total hip replacement procedure”. Can you tell from this whether it was ceramic on metal, ceramic on poly or another combination of materials from this description?
TIA
That’s good – get the tests done.
I can’t tell from the description what that hip is. Is there any more detail elsewhere in the report?
You can email me direct on earl.stevens@gmail.com