A primer on the Stryker hip implant recall

 Stryker hip implant litigation has started to crawl out of from the shadow of DePuy ASR hip implant lawsuits.  DePuy has dominated the press and with good reason: The ASR implants were pulled from the market almost two years earlier than the Styker implants. Because of this, a few of the ASR cases have already gone to trial and more "bellwether" trials continue. Stryker cases may trail in time, but not in importance. The frequency of the inquiries concerning Stryker is on the rise. So, let's cut to it with a Stryker 101 primer for Washington residents and Washington attorneys to get up to speed on certain of the basics.

History:  Stryker Corporation marketed its Rejuvenate Modular and ABG II implants [1]as being the   “latest evolution” of “next generation” hip replacement products. That sounds good. And it sounded good to numerous patients and doctors.  Buzz words sell.

The products were approved via the FDA 510K process. This is the process whereby a company can avoid clinical testing if it relies on a predicate device.  For example, for the Rejuvenate in 2008 Stryker relied on the approved Wright Medical Profemur (which in turn relied on prior predicate products). But, the Wright Medical Profemur has had its own complications: it is facing lawsuits on account of its stem breaking and particle generation caused by fretting and crevice corrosion at the head-neck trunnion joint. So the 510K "approval" only goes so far, and when it comes to safety, these hip cases have become the poster child for serious flaws with the 510K process.

Stryker’s Limited Public Acknowledgement of Problems: Surely problems with the Rejuvenate and ABG II Styker hip implants  had to have  surfaced well before Stryker publicly acknowledged any potential problems. We'll learn more (and hopefully be able to disclose more) as the litigation progresses.  Safety concerns escalated during the spring and summer of 2012. Here's a summary of some of the major events: 

• In April of 2012 Stryker issued an “Urgent Safety Alert” to surgeons for these two hip replacement systems and pointed toward safety hazards arising from excessive metal debris and/or ion generation.” The alert further highlighted other problems that can arise: metallosis (the release of metal ions into the tissue and blood stream); osteolysis (wearing down of the bone); necrosis (premature tissue death); and additional pain and loosening of the hip implant.

• In May of 2012, the Rejuvenate was recalled in Canada.

• In June and July of 2012  Stryker recalled the Rejuvenate and the ABG II in the U.S. on account of fretting and/or corrosion to the implant.  Stryker explained that this could lead to an “adverse local tissue reaction, as well as possible pain and/or swelling in or around your hip.” Naturally, this has had a major impact on those who opted for these Stryker implants.

Are these metal-on-metal?

Lawsuits concerning metal-on-metal hip implants have sprouted  throughout the nation. No longer is the dominant question whether certain metal-on-metal implants will fail. Instead, the focus has been on whether metal-on-metal in itself is the flaw. In other words, it's a matter of when, not if, the metal-on-metal implants will cause problems.  But even if  an implant escapes this gloomy forecast, the person with the implant does not.  Those who have metal-on-metal implants need to continually monitor their cobalt and chromium levels in their blood to see if metal particles have sprouted. All of this raises the question about whether the recalled Stryker models are also metal-on-metal. The short answer is they are not technically metal-on-metal, at least not in the classic sense.  Because they do not contain a metal ball that grinds against a metal socket, Styker's Rejuvenate and ABGII are not considered metal-on-metal devices. But that can be misleading. The Stryker implants suffer from many of the same problems the metal-on-metal implants cause. The classification does not tell the entire story, because  these devices are made of chromium and cobalt, with stems that are coated with titanium. They do have a metal-on-metal junction and they too can  release metallic debris into nearby tissue or into the blood stream.

What should one do if they have a Strkyer hip implant?

The first thing is to go see a hip implant doctor. This can be the doctor who performed the hip implant surgery, but often times it’s just as good – if not better – to go to a subsequent treating doctor.  A new doctor is often  not in any position to defend having chosen the Stryker hip implant in the first instance and might have more freedom from the implant company to give you an unbiased opinion.

If you are having complications or problems from your Stryker hip, you’ll also want to consider promptly consulting with an attorney. The deadlines for filing a lawsuit are strict. Getting this matter to a lawyer as soon as possible is very much in your best interest. For those in Washington State, I’d recommend – naturally – calling my law firm, Schroeter Goldmark & Bender (SGB). At SGB we handle numerous hip implant cases. We attend the latest presentations on hip litigation and strategize as to how best to handle each individual claim. Whichever firm you select, the important thing is to promptly go to a local law firm that handles hip implant litigation. I highly recommend hiring a law firm from the state you reside in.  As a Washington resident, you wouldn't hire a dentist out of Texas. So too with a lawyer: get someone who you can meet with in person. A law firm that can advise you as to whether to file a lawsuit, when to file a lawsuit, and just as important, where to file a lawsuit is critical.  The biggest take away is this: the sooner you consult with a lawyer that handles hip-implant litigation, the better.

As the litigation progresses and as more information becomes available concerning Stryker hip implants, we’ll pass the information along.

[1] These are Stryker Corporation trademarks. They are used here for informational purposes only. Nothing on this blog has been authorized or approved by Stryker Corporation.