Knee Replacement Recalls

A number of knee replacement devices have been subject to FDA recall or have been discontinued by their manufacturers due to high or early failure rates. The biggest recalls or discontinuations have involved knee implants from Stryker, Zimmer Biomet or Smith & Nephew orthopedics companies.

Am I affected by a knee replacement recall?

FDA recallKnee replacements are becoming more and more popular. People are having them earlier in life. In 2007, about 700,000 knee replacement operations were performed. By 2012, about 4.5 million people had received a knee replacement. But are these procedure safe? And should you be worried if you have a knee replacement?

Knee replacements can provide benefits. Some people have no choice. Others are able to live more active lives because of their new joint. Sadly, others have been harmed by their device and have been forced to have follow-up procedures.

Several knee replacement devices have been recalled. This is due to side effects. Many of these side effects were more painful and serious than the original issue that triggered the need for a replacement device.

What are Some of the Problems with Knee Replacements?

Many patients who had knee replacement operations now have painful side effects. Some were forced to have revision surgeries. These surgeries were to fix or replace a faulty or broken device. These procedures are also very risky and damage the body even more. And unfortunately, even when surgery is used to correct the problem, a person might not ever feel the same.

Common problems people experience after a knee replacement surgery include:

  • Infection
  • Persistent and/or severe pain
  • Swelling
  • Damage to the bone, muscle, and nerves near the device

Device failure is common. It happens more with younger patients. Some believe joint replacement devices were only designed to last for a limited number of years. Younger recipients “wear out” their devices and need new ones. In other cases, devices fail after just a few years, forcing people to ask if there was a problem when the device was made.

Zimmer NexGen Knee Recalls

There is no complete recall on any of Zimmer’s NexGen knee replacements. Many of parts of the devices have been recalled, though.

If you have a Zimmer NexGen knee, you should speak to your doctor about the chance of injury or other issues with the device.

Parts recalls include:

  • In 2010, the Zimmer NexGen MIS Tibial Components were recalled. This was due to a high rate of failure.
  • The Zimmer NexGen LPS-Flex GSF Femoral Component was also recalled due to reports of loosening.
  • NexGen MIS Tibial Components
  • NexGen TM Tibial Trays
  • NexGen LPS-Flex GSF Femoral Component
  • NexGen MIS Modular Tibial Plates and Keels

The Zimmer Natural-Knee II Durasul Patella is the subject of a Class II recall, but this part is not in the NexGen product line.

Stryker Knee Replacement Recalls

The FDA has issued a Class I recall for Stryker’s ShapeMatch Cutting Guide. The recall came in April 2013. Cutting Guides are used by surgeons and position the components by marking the bone.

Prior to the recall, in 2012, Stryker stated there were defects in its cutting guide. The company told surgeons to stop using the guides.

The recall was due to software that caused a wider cutting range than needed. This meant patients suffered injuries and unstable joints, chronic pain, and limited movement. Some needed follow-up surgery.

Other Knee Replacement Recalls

The following knee replacement products have also been recalled:

  • Stryker
    • Duracon Total Knee
    • Unicompartmental Knee System
    • Scorpio PS and CR components
  • Biomet
    • Vanguard CR
  • Smith & Nephew
    • Journey Uni Tibial Baseplate
    • Oxinium Genesis II and Profix II

What Should I Do If My Knee Replacement is Recalled?

If you learn of a recall that affects you, you should speak to your doctor to discuss your risk. Then, you should contact a lawyer to learn of your legal rights.

Do not respond directly to the recall without speaking to an attorney. Makers of your device might contact you and offer you a new device or money. You might be asked to waive your right to file a lawsuit. The maker of your device might also ask you for information and use it to limit the awards given to those who were injured.

View Sources

  1. “A ‘female’ replacement knee?” Women’s Health Advisor 10.10 (2006): 4. Academic OneFile. Web. 22 May 2013.
  2. “Class 2 Recall Zimmer NexGen LPS Flex Gender.” U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 2 Dec 2010. Web. 22 May 2013.
  3. “Knee Replacement Implants.” OrthoInfo. American Academy of Orthopaedic Surgeons, n.d. Web. 22 May 2013.
  4. “Stryker Orthopaedics – ShapeMatch Cutting Guide: Class 1 Recall.” U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 18 Apr 2013. Web. 22 May 2013.
Have you been affected by a drug or device listed? Call 855-543-7559