The Birmingham Hip Resurfacing (BHR) System, P040033, by Smith & Nephew Orthopaedics was approved on May 9, 2006 as a new expedited, first-of-a-kind premarket approval. The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head (ball) is removed to implant the femoral head resurfacing component. The BHR system is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision. More information can be found at http://www.fda.gov/cdrh/pdf4/P040033.html.
WHERE ARE ALL THE POST MARKET REPORTS AS REQUIRED BY THE PMA????
- Howard’s Lament – Lawyers dodge the tough jobs! (earlsview.com)
- Kathryn’s Story – More Smith & Nephew Birmingham Hip Resurfacing Misery… (earlsview.com)
- Jack’s call for help – Legal help sought – Cormet Hip -Isn’t there some way to get beyond PMA preemptive device approval? (earlsview.com)
- FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew (earlsview.com)
- FDA Considers Metal Hip Injuries – A Bit Too Late for Some Victims – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
- FDA panel sees little use for metal-on-metal hips | CTVNews (earlsview.com)
- Comment Example: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (earlsview.com)
- Hip replacement and resurfacing equally effective at improving joint function | Arthritis Research UK (earlsview.com)
- More Controversy over MoM Devices (defectivedruganddeviceresourcecenter.com)
- Metal-Free, High-Tech Composite Hip Implant – TMD – Today’s Medical Developments (earlsview.com)