Her Third Set of Hips after Stryker Orthopedics Rejuvenate Modular Hip System Recall

September 22, 2014, 10:30AM. By Gordon Gibb

Salem, ORStryker Orthopedics could be forgiven for initially thinking it had dodged a bullet affecting other artificial hip manufacturers having released metal-on-metal hip systems, only to be left reeling over reports of metallosis or metal toxicity stemming from the metal components. In contrast, the Rejuvenate and ABG II modular hip system was based primarily on ceramic components. But not exclusively, due to neck components fashioned from chromium and cobalt, with stems coated with titanium. Those two parts, in similar fashion to metal-on-metal hips, could wear against each other and generate Stryker Orthopedics metallosis.

The Stryker Orthopedics Rejuvenate Modular Hip System Recall happened in June 2012. A handful of Stryker recall lawsuits have been reportedly settled by way of mediation. However, well over a thousand lawsuits remain in multidistrict litigation (In Re: Stryker Rejuvenate and ABG II Hip Implant Products Liability Litigation, No. 2441), and Judge Brian R. Martinotti of Bergen County Superior Court in New Jersey has scheduled bellwether trials for June 15 and July 15 of next year.

The bellwether lawsuits are designed to serve as a test representation of lawsuits currently filed, but there are fresh lawsuits coming in. Six plaintiffs have filed a hip replacement lawsuit alleging their Stryker Rejuvenate and Stryker ABG II Hip Implants caused them harm. All six plaintiffs have either already faced or will face revision surgery. According to PRWeb Newswire (8/10/14), four plaintiffs have already had their troublesome hips replaced, a fifth has revision surgery scheduled and a sixth had not yet had a revision procedure scheduled as of August, but was expecting to.

Revision surgery is not fun, according to various reports. The procedure is more invasive than the original implantation, with the potential for heightened complication and increased healing time. Having a second surgical procedure so soon after the first can immobilize the patient, preventing them from working. Prolonged absences can put a job or a career in jeopardy.

Hip implants were historically fashioned from ceramics and for the most part worked well, allowing most patients the expectation of 15 years of continuous service under normal conditions. In an effort to continually re-invent the wheel, manufacturers came up with a design that featured metal-on-metal components. It was thought that such a design, using more robust materials, would allow implants to last even longer.

However, metal-on-metal implants were not clinically tested through normal protocols, but instead were granted 510(k) clearances due to the interpretation that the new metal components were simply an update of an existing design.

Unfortunately, it was soon discovered that metal components would wear, with minute particles of metal flaking off and inflaming surrounding tissue. Metal ions would also enter the bloodstream, causing metallosis. In other words, patients were being poisoned by their artificial hips.

A hard life made that much tougher by artificial hip failures and metallosis

That’s what happened to Kim Elizabeth Manning of Oregon. When she discovered that her metal-on-metal artificial hip was causing her cognitive problems due to metallosis, she had the hip removed in 2011 and replaced by the Stryker Rejuvenate and Stryker ABG II Hip modular implant system. In fact, she received two.

But even though the Stryker Rejuvenate and Stryker ABG II Hip Implants are based primarily on ceramic components, Manning’s cognitive problems reappeared. She was having trouble remembering basic facts and had trouble focusing on her work. According to the Statesman Journal (8/24/14), Manning would commence a task, only to completely forget what she had been doing halfway through the task, and she would have to start over. She began to suffer from severe anxiety.

Then, a year later, she learned about the Stryker Orthopedics Rejuvenate Modular Hip System Recall. An X-ray, MRI and series of blood tests at Salem Hospital revealed that Manning was suffering from Stryker Orthopedics metallosis. Chromium and cobalt, allegedly from the neck and stem of her implants, were present in her bloodstream to the extreme - at toxic levels.

As a result, Manning was forced to undergo yet another revision procedure on both hips.

Her revision surgery was completed in December of last year, and this time Manning is doing fine.

And this time she did not receive the Stryker Orthopedics Rejuvenate Modular Hip System, but rather components from another manufacturer.