Stryker Rejuvenate Put Patient “Over the Edge”

November 20, 2012, 10:30AM. By Jane Mundy

St Paul, MNJust three weeks after Nancy had a Stryker Rejuvenate hip replacement, she experienced horrendous pain that couldn’t be relieved. And things got progressively worse. No wonder she wound up clinically depressed—Nancy’s entire hip needed to be removed due to a mass of infection that contained metal shavings.

Nancy (not her real name) says that she had “manageable pain” and was able to get around with a walker for a few weeks after her hip replacement, and she was optimistic about the Stryker hip. But then things went horribly wrong.

“I went back to my hip surgeon and complained about extreme pain but he just gave me the same answer: ‘Everything appears to be in its place’, was all he could tell me, over and over again,” says Nancy. “After several visits he suspected that I could be experiencing bursitis and suggested physical therapy. I took his advice but it just made matters worse.”

Next up, Nancy had a CT Scan, with the same results: Everything was in its place. It was beginning to sound like a bad mantra. Nancy’s surgeon then hinted that her problems might all be in her head. Meanwhile, she continued to see her primary doctor for pain management and soon she needed to be medicated for depression.

“I was in severe pain and nobody could give me an answer or even try to figure out why I was suffering so much,” Nancy says. “I spent all of my time in my bedroom because it hurt so much just to move; I could barely make it to the bathroom. Then my doctor finally referred me to the Mayo Clinic in Rochester.”

The first day she was at the clinic, Nancy developed a major infection, which turned out to be MRSA—a very serious and life threatening infection. In Nancy’s case, she had a MRSA blood infection and her entire hip had to be removed. They found metal shavings in her blood, known as metallosis.

The Stryker Rejuvenate hip replacement system has been associated with metallosis, which occurs when metal-on-metal hip replacement parts grind against each other and metal shavings, which are chromium and cobalt, leach from the Stryker hip components into the tissue and bloodstream. If Nancy was given a blood test to determine whether she had elevated chromium and cobalt levels when she first complained about her hip implant, she may have been spared some agony.

As well, the surgeons at the Mayo Clinic found that the ball part of the Stryker replacement was loose. “The surgeon told me that he was able to remove it as well as the socket components with his fingers,” adds Nancy. “They found a second mass of infection behind the socket and there was a large crack in my pelvis along with major erosion. The Mayo Clinic surgeon said that the crack was most likely there at the time of the first hip replacement so it was never able to heal correctly.

"I had to go through six weeks of IV antibiotics and now I am scheduled for major pelvic construction and hip replacement. You can imagine my reaction when I found out that the Stryker Rejuvenate had been recalled.”

Stryker Orthopedics issued a major recall of its Rejuvenate hip system in July 2012. In an official release, the company said that "These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling."

Nancy and thousands of other Stryker implant patients are now facing a second surgery to replace the defective or recalled hip implant. (Stryker said about 20,000 of the affected implants had been sold prior to the recall.) In Nancy’s case, her health has been seriously compromised. She is speaking to an attorney regarding her rights and a possible Stryker lawsuit.