It looks like it’s invitation only for the FDA panel review meeting to be held in June, at which experts will discuss all aspects of the Metal-on-Metal hip disaster.
DePuy
Media Assault On Medtech Continues
Let’s face facts. Medical device regulation is by definition imperfect, however much we fiddle with it. The world’s toughest regulator is apparently a pussycat allowing devices onto the market without such as a by-your-leave. If you believe the so-well-informed media.
All-Metal Hips: Media Coverage Won’t Necessarily Aid Regulatory Reform
Did you hear the one about the company that thought it had a winner on its hands by developing its own version of an increasingly popular type of hip replacement?
UK MHRA Responds To Media Criticism
MHRA fights back against media claims that it needs to “recover its grip” over medical device regulation in light of the metal-on-metal hip situation.
Internal Emails Cast Doubt On DePuy Claims About Reasons For Halting PMA
Will we ever see through the fog in the DePuy ASR case? Internal emails now suggest product performance was a consideration in stopping the PMA and ultimate product withdrawal.
J&J Responds To New York Times
Johnson & Johnson DePuy sees fit to respond to New York Times article it claims to contain untruths regarding how it behaved during the all-metal implant situation.
Metal-on-Metal: Should FDA Concerns Have Made DePuy Act Sooner Overseas?
A new article in the New York times suggests J&J DePuy were wrong in continuing to sell product overseas after FDA raised concerns. If that happened every time FDA demanded more clinicals we might as well harmonise.
AAOS: DePuy’s New Gear
DePuy Orthopaedics unveils advancements in orthopaedic treatment at AAOS. Focus is on Clinical and Economic Value, Procedural Efficiency, Personalization.
UK MHRA Updates All-Metal Hip Status
UK MHRA updates all-metal hip guidance with statement that most patients are at low risk of developing any serious problems.
Depuy Pulls Plug On All Custom Implants Following FDA Warning
FDA warns DePuy about the use of custom device exemption to allegedly supply devices that don’t fit FDA’s definition of custom. DePuy then ceases manufacturing all custom devices.
Breakthrough In Understanding Lubrication In Metal-on-Metal Hips
Northwestern University has issued a press release about recent work published in December in Science relating to the formation of graphitic carbon, which has been identified as a naturally forming lubricant in metal-on-metal bearing surfaces in hip prostheses.
FDA Approves DePuy’s AOX ™Antioxidant Polyethylene Bearing
DePuy Orthopaedics, Inc.has received FDA Premarket Approval to use its AOX ™ Antioxidant Polyethylene material with the company’s SIGMA ® Rotating Platform Knee System and LCS ® COMPLETE ® Mobile Bearing Knee System.
DePuy Launches VIPER® Cortical Fix Fenestrated Screw in Europe
DePuy’s new VIPER Cortical Fix Fenestrated Screw features a cortical thread designed to increase resistance to pull-out forces by doubling the number of screw-to-bone contact points.
DePuy Spine Launches New Neuromuscular Scoliosis System
DePuy Spine, Inc. has this week announced the launch of the EXPEDIUM® Neuromuscular System, a new modular system designed to help surgeons address spinal and pelvic deformity in patients with neuromuscular scoliosis.
Knees Up, Procedures Up, Prices Down: Slow Growth For European Large Joint Market Over Next 5 Years
Clinical concerns about Hip Resurfacing will negatively affect growth in the Hip segment, according to a new Millennium Research Group report.
FDA in the Spotlight again as All Metal Hip Implants and Brain Stents Referenced as Examples of Harms Created by Underregulation
Republicans have been urged to hold hearings to examine certain medical devices, which have developed serious defects after being implanted in patients.