Numerous complaints of knee replacement problems have arisen over the past few months. Patients who underwent knee replacement surgery only to have the knee cause severe pain and damage have taken legal action against manufacturers such as Zimmer, Stryker, and DePuy.

OtisMed Corporation, which faced criminal charges over how it handled its knee replacement, is the most recent knee joint replacement manufacturer to face knee replacement lawsuits.

OtisMed Knee Replacement Problems

The OtisKnee presented a new option in knee replacement surgeries. The device would help knee surgeons better match a patient’s exact size and placement of the needed knee joint which could ideally lessen the amount of pain and recovery time experienced by patients. The goal was to give patients a more natural knee.

The OtisKnee itself was a cutting guide which allowed knee surgeons to make the appropriate bone cuts. Unfortunately, the severe knee replacement problems that followed have brought disturbing facts to light.

OtisMed did not receive U.S. Food and Drug Administration (FDA) approval before it began selling its knee joint replacement device. The FDA claimed that the agency even rejected OtisKnee because it did not appear to be safe or effective. Yet, OtisMed sold nearly 20,000 knee replacement devices between 2006 and 2009.

In September 2009, the FDA officially denied OtisMed’s submission due to a failure to meet safety requirements. After this announcement, the board of directors at OtisMed wanted to stop distributing the knee replacement devices. However, allegedly some OtisMed employees, including the CEO, decided to ship many OtisKnee devices and hide this distribution from the FDA.

Special Agent in Charge Thomas O’Donnell from the U.S. Department of Health and Human Services stated that OtisMed “violated the trust that patients extend to health care professionals. This outrageous behavior triggered our agency to exclude OtisMed from participating in Medicare and Medicaid for 20 years.”

OtisMed pleaded guilty in December of “intentionally distributing knee replacement surgery cutting guides after their application for marketing clearance had been rejected by the Food and Drug Administration,” according to one report. Furthermore, the company allegedly told knee surgeons that their product was exempt from FDA pre-market requirements.

OtisMed paid over $80 million in fines because of its misconduct. The CEO was also given one year in prison in addition to a $100,000 fine.

Knee Replacement Lawsuits

Hundreds of knee replacement lawsuits have been filed due to serious side effects caused by allegedly faulty knee replacement devices.

Other knee replacement problems may include:

• Premature loosening
• Severe pain
• Inflammation and swelling
• Limited mobility
• Infection
• Bone, join, muscle or neurological damage

Plaintiffs have alleged that manufacturers failed to design, manufacture, and market their knee joint replacement products safely and properly. Plaintiffs are seeking compensation for the pain and suffering caused by the allegedly faulty products in addition to the need for revision surgery.

A defective knee replacement class action lawsuit investigation has been launched.