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In recent years, manufacturers have introduced new knee replacement devices. These implants replace the cement bonding of the past – a practice that potentially broke the attached bone – with an artificial joint that fuses to the skeleton. The device features outputs for the femoral, tibia, and patella.

However, multiple recalls and studies have shed a negative light onto this medical development. A replacement joint, regardless of design, must support a patient’s body weight while allowing for mobility, and is built to provide 15 years of usage. In 2011, an Austrian study contradicted this latter statement, revealing that newer knee implants may be 30 percent less strong and have higher-than-average revision rates.

As a result, patients given these newer implants have a greater chance of experiencing a loose joint, severe pain, infection, inflammation, swelling, and neurological damage.

So far, the FDA has recalled 118 knee replacements or components over damaged parts, disassociation, mislabeled components, seize, early wear, and delamination. Some of these include:

  • Biomet Vanguard CR
  • DePuy LCS Knee Implant-Meniscal system
  • DePuy PFC Sigma Knee Systems
  • Smith & Nephew Oxinium Genesis II and Profix II
  • Smith & Nephew Journey Uni Tibial Baseplate
  • Stryker Scorpio CR and PS components
  • Stryker Duracon Total Knee
  • Stryker Unicompartmental Knee System
  • Zimmer Natural Knee System

Most have a common group of issues:

  • Breakage
  • Fractures
  • Loosening between the bone and artificial device
  • Stiffness
  • Instability
  • Wear and tear on the joint

In response, patients have needed revisions surgery, a procedure that may lead to additional complications: infection, thrombophlebitis, myositis ossificans, bone fractions, dislocation, a difference in leg length, and faster loss of bone tissue.

Zimmer

The most recent case to get attention, Zimmer NexGen CF-Flex Porous Femoral Component has been associated with loosening and pain – both signs of premature failure. While this device and the High Flex versions have not been recalled, a similar device – NexGen LPS – was taken off the market in 2010. Nevertheless, in spite of it being given to half a million patients, medical professionals have requested a recall.

A 2010 study published in the American Academy of Orthopedic Surgeons found that, out of a group of 108 patients, 8.3 percent experienced loosening and pain, and 36 percent saw evidence of radiographic loosening.

Defects, however, had been discovered in 2006. X-rays revealed that the joint and bone did not fuse fully. Four years later, Zimmer entered into a dispute with two consultants, who claimed the joint had defective parts. The manufacturer, on the other hand, laid the blame on the surgeons.

DePuy

Not a U.S. case, implants were recalled in the U.K. in 2001 because of a 67.5 percent failure rate over five years – 13 times what the manufacturer expected.

It was discovered that the parts had been sterilized with gamma radiation in the air. The chemical increases the risk of oxidation, which, in turn, may cause the joint to break.

Along with these cases, two LCS models were recalled overseas in 2008 and 2009 over increased revision rates.

Other Manufacturers

In 2003, Smith & Nephew recalled two of their knee implants, the Oxinium Pro-Fix II and the Oxinium Genesis II. Like other models, these two devices did not fully bond with the body’s bone tissue, resulting in increased rates of infection and revision surgery.

10 years later, the Stryker Total Knee System was recalled over its Shape Match Cutting Guides. Used in 2011 and 2012, these software-based guides for creating a part specific to each patient were found to have defects. As a result, the FDA issued a Class 1 recall.

Lawsuits

Multiple lawsuits have been filed against manufacturers of recalled or failing knee implants. Cases mirror the claims against faulty DePuy and Stryker hip replacements: That products entered the market without being fully tested, and a high number of patients went through painful revision surgery as a result.