Thursday, October 25, 2012

Stryker Rejuvenate – What Went Wrong

Last June 27 and 28th, the U.S. Food and Drug Administration (FDA) convened an expert panel of orthopedic surgeons. They were gathered to discuss whether the medical community should continue to trust the technology of metal-on-metal (MoM) hip replacements.

The group concluded there were few reasons to continue using MoM hips; too many patients had suffered a host of complications including metal debris in their blood stream, the creation of pseudo-tumors, dead tissue (necrosis), and an early failure rate of the implant.
This was particularly true for women and the obese.

At the time, the panelists were discussing the Johnson & Johnson DePuy ASR which had been recalled in 2010 and the Zimmer Durom Cup, taken off the market in July 2008.
Just one week later, two hip implant devices, thought to be an improvement over metal-on-metal hips, would join the ranks of the recalled amid a growing number of reports of remarkably similar and devastating patient injuries.

On July 4, 2012, Stryker Orthopaedics Corporation issued a voluntary recall of its Rejuvenate and ABG II modular-neck hip stem systems.

Stryker issued its flagship line of improved hip implants – the Rejuvenate was approved by the FDA in June 2008 while the ABG II received approval in 2009.

With a typical hip replacement, there is a ball that fits into a cap. Using a modular-neck hip stem component system, Stryker offered surgeons different sizes of stems and necks to custom fit the device to the size and activity level of their patients. That way the younger, more active patient could get back into the swing of things. At least that’s what the advertising and sales representatives said.
And since the Rejuvenate has a ceramic ball that fits into a socket with a plastic liner, there were no metal surfaces to rub, therefore no problem with metal debris. At least that was the theory.
Remember that unlike drugs, the bulk of medical devices do not have to prove safety and efficacy before they are sold to you, the public. It was in the landscape of patient use that that theory was put to the test.

That was where we saw the Rejuvenate’s similarity to MoM hips.

A modular system is a two piece system. The metal stem and metal neck attach and then connect to the ball. It is at the area where the neck meets the stem where the device failed and we now know is causing the same problems as metal hips, the same problems patients thought they had avoided.
The neck of the Stryker hip is made of chromium and cobalt, the stem has a coating of titanium and there is a metal-on-metal intersection that can deposit metal debris into the body from a degree of grinding.

Back in April, the company knew it had problems.
Stryker issued an Urgent Safety Alert that went to surgeons and hospitals warning that metal ion debris could be generated by “fretting and/or corrosion at or about the modular neck junction.” That junction could increase metal particles in the surrounding joint space causing adverse tissue reaction including:
  • Metallosis (metal toxicity from grinding metal components)
  • Necrosis (premature tissue death)
  • Osteolysis (bone dissolution)
  • Pseudotumor formation
  • Pain requiring revision surgery
While most hip implants are expected to last 15 years on average, the Rejuvenate and ABGII began failing after just several months.

So far, there have been 60 adverse event reports and those have been increasing dramatically since the beginning of 2012.

Searcy Denney now represents well over 100 Rejuvenate and ABGII victims from 15 states and we were the first law firm to file litigation on behalf of those suffering multi-organ injuries from toxic metals of cobalt chromium and titanium as well as requiring multiple surgeries to remove the defective devices.

We predicted Stryker’s products would be next from the reports we’ve been hearing. It’s too bad the company did not let the medical community know what it was planning last June.

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