Knee Replacement Recalls

FDA recallKnee replacement procedures are becoming increasingly popular. In 2007 alone, an estimated 700,000 knee replacements were performed. The American Academy of Orthopedic Surgeons stated that by 2012, roughly 4.5 million Americans received a knee replacement. This translates to roughly five percent of American adults over the age of 50. Knee replacement procedures have restored vitality and mobility to patients around the world.

While knee replacement devices have benefited a number of patients, many have caused harm. A number of knee replacement recalls resulted from unexpected side effects caused by total knee replacement systems and components of knee replacement systems. Manufacturing companies currently face lawsuits from patients who have been injured by these devices. Patients who experience complications are encouraged to file reports, as these may help the FDA and manufacturers determine if a knee replacement recall is appropriate.

Knee Replacement Recall Complications

A number of patients who had knee replacement operations have reported debilitating side effects. In many cases, these complications required the patient to undergo revision surgery. Revision surgery is a second operation that is used to fix or replace the device. Revision surgery may also be used to correct complications caused by the device.

Complications that may contribute to a knee replacement recall include:

  • Persistent pain
  • Infection or drainage
  • Swelling or inflammation
  • Damage to surrounding bone, muscle, or nerves

Zimmer NexGen Knee Recalls

While there has not been a total recall on any Zimmer NexGen knee replacement devices, a number of device components have been recalled. In 2010, Zimmer NexGen MIS Tibial Components were recalled due to high incidences of failure associated with the components. The Zimmer NexGen LPS-Flex GSF Femoral Component was also recalled due to evidence of loosening. Additionally, the Zimmer Natural-Knee II Durasul Patella faces a Class II recall. This component is not part of the Zimmer NexGen product line.

Zimmer NexGen knee recalled components include:

  • NexGen MIS Tibial Components
  • NexGen TM Tibial Trays
  • NexGen LPS-Flex GSF Femoral Component
  • NexGen MIS Modular Tibial Plates and Keels

Stryker Knee Replacement Recalls

In April 2013, the FDA issued a Class I recall of Stryker’s ShapeMatch Cutting Guide. ShapeMatch Cutting Guides are made for use by surgeons. The Guides help to position knee replacement components and guide the marking of the patient’s bone prior to cutting. In November 2012, Stryker acknowledged manufacturing defects in the ShapeMatch Cutting Guide and instructed surgeons to discontinue use.

This knee replacement recall was due to the fact that the software has a defect that causes wider cutting ranges. As a result, knee replacement patients may experience severe complications such as instability of the joint, fracture, chronic pain, and mobility limitations. Patients may also require the need for revision surgery.

Other Knee Replacement Recall Products

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

Responding to a Knee Replacement Recall

Before responding to a knee replacement recall, patients should speak with an experienced attorney to discuss their legal rights. After a knee replacement recall, the product manufacturer may offer patients a new implant or other forms of compensation. In many cases, patients waive their rights to file a lawsuit against these companies by accepting offers from the manufacturer.

Additionally, manufacturers may attempt to collect information from patients regarding their injuries from recalled devices. Manufacturers may then use this information to limit the financial compensation awarded to patients who have experienced injury. An attorney can help inform patients of their legal rights, as well as how to handle the process of seeking compensation for injuries caused by knee replacement recall products.

View Sources
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  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.