DePuy

DePuy staff are still sounding defiant, but it’s not looking like the engineering group looked under every rock in establishing the safety and longevity of their ASR device. And then, when warned of issues, the claim is that the company didn’t act quickly enough.

More coverage from the trial between Kransky and DePuy has the all-metal hip maker feeling the heat from revelations that it hid the building concerns of orthopaedic surgeons about its device for a long time before the eventual recall.

Bloomberg has reported on the pre-trial testimony of Paul Voorhorst, a DePuy biostatistician, as a preamble to proceedings in the case of Loren Kransky vs J&J (DePuy), for which the jury sits tomorrow (Friday 25th January). In it, previously unseen documents suggest that the company’s own estimates of failure rate for some of its metal-on-metal hip prostheses are now as high as 37%, significantly higher than the 12 or 13% cited in the original recall notices.

Settlement amounts have been approved for the DePuy Hip Implant litigants in Australia, fueling hopes that U.S. settlements are nearing. The Australian National Joint Replacement Registry, which began reporting problems to DePuy in 2007, led the fight to have the devices removed from the market.

Johnson & Johnson’s DePuy Synthes Spine business has a new Worldwide president in the form of Max Reinhardt, a long term employee of the company and most recently Vice President of Worldwide Marketing.

DePuy Synthes Spine has announced new image guided instrumentation for two of its leading spine systems and has entered into a new partnership agreement with Brainlab, enabling both companies to offer integrated surgical navigation and imaging solutions.

DePuy Synthes Spine has announced the launch of the Spotlight® PL Access System, the first access system designed specifically for minimally invasive posterior-lateral fusion.

Orthopaedic and Sports Med company DePuy Mitek, Inc., has announced the launch of the Healix Advance™ Family of Suture Anchors, a comprehensive new system of rotator cuff anchor and instrumentation solutions. The company says its new anchor design will enable faster insertion into hard bone and maximise fixation and pull-out strength.

Orthopaedic and Sport Med device company DePuy Mitek, Inc.has announced the launch of Endurance Hip Solutions, a new system of instruments and devices that marks the company’s entry into the rapidly growing field of hip arthroscopy.

DePuy Synthes Spine has received FDA 510(k) clearance for use of its EXPEDIUM®(pictured), VIPER®, and VIPER®2 Spine Systems on patients with adolescent idiopathic scoliosis (AIS), expanding the scoliosis indication for the pedicle screw systems, previously only approved in adults.

In this guest editorial, submitted by John Martin of legal marketing specialist firm eJustice, he reports on FDA’s most recent review of the ongoing all-metal hip debacle.

According to a press release issued by US Law firm Bernstein Liebhard LLP, FDA has received almost 17,000 adverse event reports from 2000-2011, associated with metal hip implants, such as the DePuy ASR and Pinnacle hip systems. An FDA panel has been in session for two days to discuss the situation.

The big surprise in this new study, published at AANA this week, is that it’s taken so long for researchers to put a figure on the cost savings to be had in saline consumption alone by using an inflow/outflow computer controlled arthroscopic pump rather than inflow only. Maybe its just a sign of the times that it’s even become an issue.

There was an inevitability about the whole thing, but still J&J and Synthes execs must be relieved that the EU commission into their mega deal has agreed to the takeover following J&J’s concessionary divestiture of its existing trauma business. Wonder how those guys are feeling though.

DePuy Spine’s Viper® F2 Transfacet Pedicular System is launched at AANS.

Biomet has an exclusive, binding offer of $280M on the table for J&J’s DePuy Trauma division. The deal is thought to represent J&J’s concession, extracted from the leviathan by an EU commission, in order to ratify its $21Bn takeover of Synthes.