US Drug Watchdog Now Calls All Metal Hip Implant Failures the Biggest Disaster Ever
US Drug Watchdog Now Calls All Metal Hip Implant Failures the Biggest Disaster Ever for up to 500,000 U.S. Citizens …
Monthly Archives: July 2012
Hip implant materials swing sharply to polyethylene | PlasticsToday.com
Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …
NIH adds more information on hip replacement in its NIHSeniorHealth.gov website
NIH adds more information on hip replacement in its NIHSeniorHealth.gov website. NIH adds more information on hip replacement in its …
Smith And Nephew Hip Replacement Recall Lawsuit Attorney
Smith And Nephew Hip Replacement Recall Lawsuit Attorney. Saunders & Walker PA 3491 Gandy Blvd. North Suite 200 Pinellas Park, …
FDA to help medical device sales with expanded pre-market feedback program
FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …
Newer hip reconstruction technique provides good outcomes for athletes
Newer hip reconstruction technique provides good outcomes for athletes. Public release date: 14-Jul-2012 Contact: Lisa Weisenberger lisa@aossm.org 847-655-8647 American Orthopaedic …
Bernstein Liebhard LLP Launches Stryker Hip Recall Lawyer Website – SFGate
Bernstein Liebhard LLP Launches Stryker Hip Recall Lawyer Website – SFGate. Bernstein Liebhard LLP Launches Stryker Hip Recall Lawyer Website …
Smith & Nephew BHR FDA-required Post-Approval Studies
Smith & Nephew BHR FDA-required Post-Approval Studies Post-Approval Studies In January 2005, the oversight responsibility of the Post-Approval Studies Program …
Consider other options before Joint Surgury – Stephen S. Rodrigues, MD
Consider other options before Joint Surgury – Stephen S. Rodrigues, MD I am a family doc in Dallas TX, in …
No cancer rise in hip implant patients – Health – Fleetwood Weekly News
No cancer rise in hip implant patients – Health – Fleetwood Weekly News. No cancer rise in hip implant patients …
Patient undergoes four joint replacement surgeries – Times Of India
Patient undergoes four joint replacement surgeries – Times Of India. Patient undergoes four joint replacement surgeries Umesh Isalkar, TNNJul 11, …
‘Toxic’ hip replacement fears – Health – Belfast Newsletter
‘Toxic’ hip replacement fears – Health – Belfast Newsletter. ‘Toxic’ hip replacement fears Published on Saturday 14 July 2012 09:28 …
Failing metal hip implants could be releasing toxic nanoparticles
Failing metal hip implants could be releasing toxic nanoparticles. Failing metal hip implants could be releasing toxic nanoparticles Scientists have …
As lawsuits climb, J&J may have new hip trauma – Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending
As lawsuits climb, J&J may have new hip trauma | Smart Business. As lawsuits climb, J&J may have new hip …
Smith & Nephew’s BHR PMA approval by the FDA despite lack of scientifically valid trials and BHR Conflict of Interest
FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …
FDA to guide device makers on marketing application – chicagotribune.com
FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …
Stryker Recalls Two Metal-on-Metal Hip Implants
Stryker Recalls Two Metal-on-Metal Hip Implants. Stryker Recalls Two Hip Implants July 9, 2012 — Stryker Corp. announced a voluntary …
Stryker Recalls ABG II and Rejuvenate Modular-Neck Stems for Risks Posed by Corrosion and Wear : US Recall News
Stryker Recalls ABG II and Rejuvenate Modular-Neck Stems for Risks Posed by Corrosion and Wear : US Recall News. Stryker …
Defective Hip Implant Lawyers Offer Free Case Reviews for Stryker Hip Implant Claims – Times Union
Defective Hip Implant Lawyers Offer Free Case Reviews for Stryker Hip Implant Claims – Times Union. Defective Hip Implant Lawyers …
Dr Stephen (Steve) Tower to Join the Earl’sview site – to answer patient questions
Earlsview Over the year since I set up Earlsview as part of my “anger management” the site has had nearly …
About Metal-on-Metal Hip Implants
About Metal-on-Metal Hip Implants. About Metal-on-Metal Hip Implants If you or your loved one has endured a MoM hip implant …
Smith & Nephew – Class 2 Recall R3 Constrained Acetabular Liner
Medical & Radiation Emitting Device Recalls. Class 2 Recall R3 Constrained Acetabular Liner Date Posted October 18, 2010 Recall Number …
FDA – User Fees for Medical Devices: Third Time Lucky?
User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …
Stryker recalls two metal-on-metal hip products for fear of corrosion
Stryker recalls two metal-on-metal hip products for fear of corrosion. Stryker recalls two metal-on-metal hip products for fear of corrosion …
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2
June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1
June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …
Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants
Long-Term Health Risks Associated with Genotoxic Nanoparticles Released by Failing Metal-on-Metal Hip Implants. Long-Term Health Risks Associated with Genotoxic Nanoparticles …
Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit
News Headline Story | equities.com. Biomet M2a Magnum Metal-on-Metal Hip Replacement Lawsuit Alleges Defective Implant Caused Oregon Woman to Suffer …
FDA releases proposed UDI rule; reaction generally positive
FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …
METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY
CTAF ASSESSMENT – METAL ON METAL TOTAL HIP RESURFACING AS AN ALTERNATIVE TO TOTAL HIP ARTHROPLASTY http://www.google.com.au/url?sa=t&rct=j&q=&esrc=s&source=web&cd=42&ved=0CFIQFjABOCg&url=http%3A%2F%2Fwww.ctaf.org%2Ffiles%2F769_file_Hip_resurfacing_W.pdf&ei=Ovr4T5bGI-yUiAfA5tzhBg&usg=AFQjCNGpF8andIjM3eQZ9JGMI58FwHyo7w&sig2=IPuN6AUkPw1Tt6yzEYt32Q. Or download the …
Joint Replacements For Baby Boomers
Joint Replacements For Baby Boomers. Joint Replacements For Baby Boomers MARILYNN MARCHIONE 05/23/11 09:56 AM ET SHARE THIS STORY SAN DIEGO …
Hip resurfacing: A boon for Boomers or too risky?
Hip resurfacing: A boon for Boomers or too risky?. Hip resurfacing: A boon for Boomers or too risky? By Annie …
Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for safety, efficacy and improvement in health outcomes for patients as an alternative to total hip arthroplasty
Metal on metal hip resurfacing using the BHR, Cormet 2000, or Conserve Plus devices does not meet CTAF criteria 3-5 for …
Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics
Early Clinical Experience With the Use of the Birmingham Hip Resurfacing System | Orthopedics. Early Clinical Experience With the Use …
Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems
Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM310217.pdf. This is a PDF …
Outcomes of Birmingham Hip Resurfacing: A Systematic Review
Outcomes of Birmingham Hip Resurfacing: A Systematic Review. Asian J Sports Med. 2012 March; 3(1): 1–7. PMCID: PMC3307960 Outcomes of Birmingham Hip Resurfacing: …
FDA Executive Summary Memorandum – Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel Gaithersburg Hilton, Gaithersburg, Maryland
FDA Executive Summary Memorandum Metal-on-Metal Hip Implant Systems Prepared for the June 27-28, 2012 Meeting of the Orthopaedic and Rehabilitation Devices …
SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies
SMITH & NEPHEW BHR – FDA Papers – Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309356.pdf. Download PDF …
Smith & Nephew BHR – Food and Drug Administration, HHS
http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …
SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEMf
Source: www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4181b1_03_SSED_BHR_080505.pdf. SUMMARY OF SAFETY AND EFFECTIVENESS DATA PREMARKET APPROVAL APPLICATION P040033 SMITH & NEPHEW BHR BIRMINGHAM HIP RESURFACING SYSTEM …
Attachment B – Ragab AA., validity of Self-Assessment Outcome Questionnaires: Patient-Physician Discrepancy in Outcome Interpretation, 39 Biomed. Sci. Instrum. 579-84 (2003)
http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-cp00001-03-Attachment-B-vol1.pdf. Biomed Sci Instrum. 2003;39:579-84. Validity of self-assessment outcome questionnaires: patient-physician discrepancy in outcome interpretation. Ragab AA. Department of Orthopedics, …
FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, at 12 (Sept. 8, 2005)
FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …
Attachments to Wright Medical’s request to Deny PMA to Smith & Nephew BHR
Dockets:. Dockets Management Back 2005P-0440 CP 1 Volume 1 Citizen Petition Attachment A - FDA, Summary Minutes, Meeting of the Orthopedic …
FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…
FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr. Roberts: Food and Drug …