The clinical trial was run with 194 patients over a 2 year period and 5 patients either needed a replacement or revision surgery. After the massive recalls I just have to ask the question, would the public and doctors be trusting of another similar hip implant since all of the recalls on the ASR product line? Maybe this is just bad timing for the announcement.
DePuy (Johnson and Johnson) Issues Recalls Hip Replacement Systems And Commits To Working with Related Cost
Not being an orthopedic surgeon there’s no way I can comment on the design as I am not qualified but I can sure be concerned as others may be on the device, and on the other hand is this a potential replacement for those that were recalled as if patient go back under for another unit, a selection of some sort has to be used. BD
The first ceramic-on-metal implant for total hip replacement has been approved by the FDA, the agency announced.
The Pinnacle CoMplete Acetabular Hip System is manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, and based in Warsaw, Ind.
The femoral head portion of the implant is made of ceramic and the acetabular (socket) component is a metal alloy.
With this approval, there are now five different combinations of materials from which hip implants can be made. Others already approved include ceramic-on-ceramic, ceramic-on-polyethylene, metal-on-polyethylene, and metal-on-metal.
The Pinnacle product approval was based on a two-year, randomized clinical trial, which found no clinical difference between 194 patients who received the ceramic-on-metal system and 196 patients receiving a metal-on-metal implant.
Medical News: Ceramic-on-Metal Hip Implant Wins FDA Nod - in Orthopedics, Orthopedics from MedPage Today
I hope this won’t have the same fate as the other hip implants released. The Asr hip replacement recall has affected many and the issue is still on. The number of alleged faulty device implanted worldwide is no small number.ReplyDelete