Hip

Some patients in some situations still benefit from metal-on-metal hips. The FDA has now issued a guidance document, laying out its considered view on the use of these devices, including ongoing assessment of patients already implanted with them.

Biomet has released its financial results for the most recent quarter, showing a net sales increase of 9% compared with a year ago. Income and earnings showed similarly healthy increases, although one-off costs translated into a significantly bigger net loss than in the equivalent period.

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.

Medical professionals are always right. They must be, because we don’t bother to regulate their practices, let alone require formal centralised approval of new techniques prior to their introduction. Meanwhile the device industry is increasingly regulated. We ask whether this is all entirely the best way of doing things.

UK based MIS device company Surgical Innovations (SI) chose last week’s International Society of Hip Arthroscopy (ISHA) meeting in Boston, at which to showcase its pre-production hip arthroscopy products.

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.

UK device company Surgical Innovations welcomed some of the best minds in UK surgery to its annual event last week in what forms a key part of the company’s surgeon-led product and idea-development philosophy.

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.

Stryker has undertaken a voluntarily global recall for its Rejuvenate and ABG II modular-neck stems because of post-marketing surveillance data which suggests a potential risk of what it has termed “fretting and corrosion”.

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.

Smith & Nephew had already issued a Field Safety Notice on its R3 metal acetabular liner. Now MHRA has followed up with its issuance of a Medical Device Alert including direction on patient follow-up.

Device company Mindray Medical International Limited, is to acquire a controlling stake of Wuhan Dragonbio Surgical Implant Co., Ltd. signalling its intent in the trauma, spine, joint and other surgical products arena.

Smith & Nephew is withdrawing a component of one of its all-metal artificial hip systems following a higher than normal level of patient problems with the device. The fact that the recall was provoked by clinical outcome data points to the potential power of implant registries in regulating surgical implants.

So the EU (European Commission) funds a collaborative project to develop a technology that addresses a very real (and rather high profile) clinical need. Collaborating companies benefit and so thrive and employ more people, in so doing addressing the need to do just that. This new continental collaborative concept might just work and if it does everyone’s a winner.

When politicians get involved in issues some of us have spent decades involved with, the result is bound to have a few badly thought through components. In the case of the European MEPs they’ve done an acceptable job of identifying the medtech regulatory issues, tinged with a bit of populist reactionary stuff that would serve nobody.

Nanotechnology to combine HA and Growth factors could be the best coating solution for inducing osteo-integration of hip and knee prostheses, trauma products, dental implants.