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Michael Monheit
Michael Monheit
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Wright Profemur Z Hip – Is an 11.2% Failure Rate Too High?

4 comments

Substantial Failure Rate
Countless patients encounter hip problems. As a result, they often turn to hip implants to alleviate their pain and help them move around without lingering pain or discomfort. Recently, however, hip implants have been creating additional health problems rather than mitigating them. The DePuy hip recall has been well documented, with one in eight patients requiring revision surgery. But DePuy isn’t the only company who has manufactured potentially defective hip implants. According to a recent study from the Australian Joint Registry, the Wright Medical Technologies Profemur Z hip implant has created substantial hardships for patients. In fact, at the three-year interval the statistics reveal an 11.2% failure rate.

Lawsuits
The failure rate has not gone unnoticed. There have been lawsuits filed against Wright recently. Among those, a Colorado man filed suit alleging that his Wright Profemur hip system failed after three and a half years, resulting in revision surgery. The man claims in the lawsuit that the Wright hip replacement failed due to a defective and negligent design.

Hip Implant Design
The Wright model, however, wasn’t supposed to create any problems. Instead, it was supposed to be an evolutionary design. The Wright website says, “The unique modular neck component allows soft tissue balancing and easy restoration of the hip joint center of rotation. This modular approach to implant design provides surgeons with unsurpassed options for primary and revision hip surgery.”

The implant was supposed to be an ideal implant for minimally invasive surgery. In fact, the FDA approved the model. The questions, however, are in light of the problems associated with the model, why was it approved by the FDA and why hasn’t a recall been mandated? The answers to those questions remain to be seen.

Conclusion
Hip implants can greatly improve the quality of life for patients. That improvement, however, only occurs if the implants are designed correctly. To be sure, implants which aren’t properly designed can be counterproductive. In fact, they can add to people’s health problems rather than solve them by requiring early revision surgery and other complications. A hip implant should not cause you more problems than you already deal with on a daily basis. If it has, you should make sure this is reported to the FDA and that the manufacturer is held accountable.

Product Identification Notice: In any of our web pages referring to Zimmer NexGen products, these pages are intended to provide information about and are referring to the same Zimmer products that were identified by Dr. Berger in his presentation and study entitled "The High Failure Rate of a High-Flex Total Knee Arthroplasty Design," and were written about in the NY Times article titled "Surgeon vs. Knee Maker: Who’s Rejecting Whom?," and that are reported in the FDA MAUDE database, where reports involving the Zimmer NexGen CR Flex Cementless or Porous Femoral component can be found and also those products associated with aseptic loosening of the Zimmer MIS Tibial Component that led certain doctors to discontinue its use, and to recommend discontinued use of this product in primary TKA until the etiology of the high early failure rate of this implant is determined. See prospective studies comparing the results of the Zimmer MIS Tibial Component using conventional and minimally invasive exposures as well as comparing fixation with different types of bone cement as described in Early Aseptic Loosening With a Precoated Low-Profile Tibial Component A Case Series. Not all Zimmer NexGen products are involved in our investigations and lawsuits.

4 Comments

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  1. up arrow

    I want to restate a point, that was made to me by a reader, that not all implants are problematic, and not all models by a specific manufacturer, e.g. Wright, Zimmer, DePuy, are causing problems. Of course there are millions implants each year, including both knees and hips. And the vast majority of surgeries are without problem. Most products, thankfully, perform as promised. However, sometimes a product comes to market and does not perform acceptably. I think that often innovation is driven by a desire to out do the other manufacturer’s products, and sometimes the technology does perform as it was represented. When this happens, patients (and their doctors) can suffer the consequences of promised benefits not being delivered and injuries being suffered as a result. The market is competitive with companies seeking a groundbreaking design in order to win market share. I saw this same phenomenon first hand with clients who took some of the newer birth control products, sold to gain market share with no real new benefits, and then gaining market share at the unfortunate expense of product safety.

    So, while not all DePuy hips failed, the ASR model presented significant problems. While not all NexGen products are in the midst of the controversy, Dr. Berger has identified problems with failure of the knee product he used for years in patients. While not all Wright models are subject to lawsuits, lawsuits have been filed for the Profemur Z Hip system.

    Each patient must, in consultation with their doctor, weigh the risks and benefits of the implant they choose. In order for this to be done properly, manufacturers need to provide accurate data to the doctors so that an informed decision can be made. For the specific risks and benefits of the product you are considering, review the data with your doctor. Reports on product problems can be found here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

  2. Lise Markham says:
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    Please, let’s stop with this stuff about a patient
    needs to know the risks and benefits. Did we go to med school? No. Do we have a national joint registry so we can know about failures? No. Do we know if our OS gets monies from the device manufacturers? No. Does this FDA pull products after “x” complaints? No. I can go on. These devices under the 510(k) clearance are a joke. Hips of 10 years ago worked. That’s not what is available now. The “new and improved” hips are out there to make money. They backfired. The only way to change this is for the FDA to demand clinical trials on ALL devices put inside one’s body. Period. Patients have no control over this right now.

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    @Lise: Thank you for your comment. I agree with your conclusion that the newer products are driven by profit motive and not by better science or better design. I also agree that the 501(k) process subjects patients to signficant and unnecessary risks. All devices should be tested, and clinical trials should last much longer to find the problems before products are massively introduced into the market. But I also think that the data on failures needs to be made more available to both doctors and patients, so that light is shed on the devices that are problematic.

  4. tom says:
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    There are a few things that I think are being missed.

    I think a national joint registry is a good idea and most surgeons and companies would all agree with this. With that being said you have to be able to interpret the data from the registry properly. With regards to the Austrailian Registry Wright data you must ask a few questions; how many surgeons used implant, how many implanted, what was mode of failure etc. You also have to remeber that the patient population has typically become younger, more active, and heavier from say 10 years ago. You can’t solely look at high survivor ships from 10 and 20 years ago and expect the sames survivorship with the current generation of patients.

    Patients, especially in the US, are constantly demanding the latest and greatest in joint replacements. Patients are also requiring surgery at a lot younger age. This demand places a lot of preassure on surgeons as well as companies to keep up with demand. Surgeons a lot of time face pressure by patients asking for the latest and greatest as well as seeking out physicians who put in a certain implant they saw on the internet.

    Is everyone aware of the time, effort, and money required to conduct clinical trials for implants prior to clearing them for use? If you did away with the 510k process completely in favor of the clinical trial method you will in turn see a sharp decline in new technology being availible to patients and higher cost for technology that goes throught the process.

    I agree there does need to be more disclosure to patients in terms of what exactly they are being implanted with and the risks involved, some form of a national registry, and some standards set on product approval. I also think that there needs to be regulations on when and for what cause companies can be sued with regards to medical devices. There is a large group of lawyers who wait for any opportunity to sue large corporations. I feel that this constant birage of lawsuits overshawdows the ligitimate claims and clouds the scientific debates over implants. I would say that patients should be offered old more proven technology or the latest and greatest and let them decide. At the rate things are going I would also be for liability waivers for patients wanting the new implants.

    In regards to the specifics of the Wright Profemur implant. I briefly looked at this and his type of implant has been around for a long time. Wright actually purchased the technology from another company and it has around 20 years of use.