Hip prosthesis

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.

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.

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.

Study into Cancer risk in the first seven years after Metal-on-Metal Hip Replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics.

UK MHRA singles out specific combinations of hip/stem for attention, this alert proving the value of the data in England and Wales Joint Registry.

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.

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?

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.

MHRA provides advice on follow-up systems for all-metal hips to include testing of all patients with large diameter femoral component and all ASR hips.

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.

It’s a bit of a journalistic open goal when BBC publishes on the fate of “cremated” prostheses at the same time as we’re wondering about the fate of the Costa Concordia. Sounds like they might both end up as wind turbines.

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.