FDA Approved Hip Resurfacing DevicesBHR – Birmingham Hip Resurfacing System by Smith & Nephew Corin Cormet Hip Resurfacing Device withdrawn from US Market 2013 Wright Medical Conserve Plus Hip Resurfacing Device withdrawn from US Market 2014
The Birmingham (Smith & Nephew, Richards) total HSR was the first to get FDA approval in the US based on an unprecedented FDA decision to approve this implant on the basis of single (developing) surgeon’s foreign data. Cormet 2000 ( Corin Ltd., Stryker) total HSR was the first to be approved based on the usual mechanism of a US run Multi-center FDA study( approval 7/2007, I was the lead investigator). Therefore, there are now 2 implants available in the US that have an FDA indication for total HSR.The Recap/Magnum (Biomet), Conserve Plus (Wright Medical) and ASR (Depuy) are all also FDA approved implants in the USA. They may be legally used by any surgeon for the purpose of total Hip Surface Replacement. (The FDA… Read the rest
|FDA to Stryker: Fix hip implant flawsLink to Original Article SNBC
By LINDA A. JOHNSON updated 5:48 p.m. ET, Wed., Jan. 16, 2008
TRENTON, N.J. – Federal regulators have ordered medical device maker Stryker Corp. to fix a host of long-standing problems in its manufacturing of hip replacement parts that have triggered multiple patient complaints and forced some to have follow-up surgeries. Stryker shares fell almost 2 percent.
May 9, 2006
|U.S. FDA to Collect Adverse Event Data Despite UK Recall of Metal Hip Implants http://fdanews.com/newsletter/article?issueId=14568&articleId=135224 Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the U.S. Food and Drug Administration (FDA) says. National Joint Registry of England and Wales data, which last year showed high revision rates for two ASR hip resurfacing systems, led to a UK medical device alert and recommended blood tests, as well as a worldwide J&J recall in August. But the FDA argues the adverse event rate for these devices remains unclear, and the agency is in the process of gathering additional information about adverse events in people with MoM hip implants.|
Date Issued: Jan. 17, 2013
Medical Specialties: Orthopaedics, General Medicine, Family Practice, Radiology, Radiologic Technology, Clinical Laboratory Managers and Directors
Device: Metal-on-metal hip implants consist of a ball, stem and shell, all made from cobalt-chromium-molybdenum alloys.
There are two types of metal-on-metal hip implants1:
Purpose: In February 2011, the FDA launched a metal-on-metal hip implant webpage2. The FDA is providing updated safety information and recommendations to patients and health care providers. This new information is based on the FDA’s current assessment of metal-on-metal hip implants,
A letter about FDA Approvals and Off Label Hip Resurfacing Components by Dr. Gross
The Birmingham (Smith & Nephew, Richards) total HSR was the first to get FDA approval in the US based on an unprecedented FDA decision to approve this implant on the basis of single (developing) surgeon’s foreign data. Cormet 2000 (Corin Ltd., Stryker) total HSR was the first to be approved based on the usual mechanism of a US run Multi-center FDA study (approval 7/2007, I was the lead investigator). Therefore, there are now 2 implants available in the US that have an FDA indication for total HSR.
The Recap/Magnum (Biomet), Conserve Plus (Wright Medical) and ASR (Depuy) are all also FDA approved implants in the USA. They may be legally used … Read the rest
The Food and Drug Administration has proposed a program that would query public and private databases to help study the efficacy of orthopedic implants.FDA will issue a request for quotations next month in an effort to identify companies that could evaluate orthopedic implant registries for participation in the program. The program is part of the broader Sentinel Initiative FDA launched earlier this year. The broader effort is intended to monitor and provide early warnings of potential problems with FDA-approved medical products. The implant program would “create a national network of registries for the FDA in support of the Sentinel Initiative,” according to an FDA announcement posted July 25. Implants of interest would include total
|FOR IMMEDIATE RELEASE July 9, 2012Contact: HHS Press Office (202) 690-6343 Statement from HHS Secretary Kathleen Sebelius on the signing of the Food and Drug Administration Safety and Innovation Act Today, the President signed into law S. 3187, the “Food and Drug Administration Safety and Innovation Act.” This legislation, which passed both the House and Senate with overwhelming bipartisan majorities, will help speed safe and effective medical products to patients and maintain our Nation’s role as a leader in biomedical innovation. S. 3187 is the culmination of the work of the administration and Congress, in partnership with patients, the pharmaceutical and medical device industries, the clinical community, and other stakeholders, to provide the Food and Drug Administration with the tools needed to continue to bring|