Pamela's orthopedic surgeon suggested that she participate in the Zimmer study. "This type of Zimmer knee was a new product and not experimental, and having worked in a teaching hospital I was anxious to participate," says Pamela, adding that the study took place at the University of Virginia, strictly on a volunteer basis, no payment was involved."The surgery went well and I did everything by the book," says Pamela, "but three years later I walked down some steps and my knee buckled, like it had done before the surgery. I put ice on my knee and rested, but it happened several more times that day. It didn't hurt, but it did feel unstable and unsteady, like something was slipping a notch."
Pamela went back to her surgeon and had a second X-ray—she'd had one just a few months prior that showed nothing untoward. "But this X-ray showed a ¼-inch gap, and my surgeon said it wasn't solidly attached," explains Pamela. "He asked me if I had fallen—I hadn't. He said to give it a few months and let him know if I experience any pain or swelling; he certainly didn't seem concerned, but I was.
"Sure enough, my knee began to swell and it got to the point where I was worrying that I might fall. So back to the surgeon and based on my symptoms, he said that I needed revision surgery: no surgery is perfect but this was horrific.
"Next day after the revision surgery, I asked my surgeon what he found wrong with my knee. He told my husband and me that nothing was wrong with it. 'In that case, was there something wrong with the device, is this second knee another Zimmer?' my husband asked. He told us that I now had a DePuy replacement. 'We aren't using Zimmer knees anymore,' he said. To us, that sounded like an admission of a defective knee.
"Because the study ended so abruptly, my interpretation is that my knee had failed and they were no longer using that particular model. And I never got the study results. In fact they stopped sending me any paperwork about two years after the study began. They never said how long the study would last, but there was no finality, I never got a letter saying it was over.
"Because the study ended this way, I am very curious and concerned. I need to know if my knee failed just after three years because there was a problem with my body (I had back surgery years ago that didn't go well) or whether I had a faulty device. If it was the latter, I could breathe easier knowing it wasn't my body rejecting it. I made a few calls to the University hospital; I wanted to know the results of the study. But I never even got a response. I believe that Zimmer owes an explanation—even if the results are inconclusive—to those people who participated. It was odd that there was no completion survey.
"I am not bitter, but when bad products are involved, manufacturers need to be accountable and the medical community must be transparent: that should be the norm and not the exception. Having said that, I probably sound naïve and idealistic but that is what has made me a good nurse for all these years.
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"It has certainly curtailed my lifestyle. For instance, if it's icy outside, instead of putting on boots and taking my dog for a walk, I have to stay home. I have to be very careful, like living under a 'what if.' It's very stressful and I've been on anti-depressants since the second knee replacement. Most troublesome with revision surgery is that if something goes wrong, there's no place to go: I don't think you can do anything more after a revision and that is my major worry. I am now 64 and have a lot of active years left, but if I fall or have any injury, this is my last knee and that keeps me awake at night."