The Zimmer Biomet Comprehensive Reverse Shoulder is a device that is surgically implanted to help patients restore arm movement. Those with rotator cuff tears or severe shoulder arthritis were some of the intended patients for this device. Instead of improving arm movement, however, the implant caused several problems and, on December 20, 2016, Zimmer Biomet recalled these devices due to their tendency to fracture, necessitating revision surgeries that had the potential to cause serious consequences.
In addition to Zimmer Biomet’s Urgent Medical Device Recall Notice, the U.S. Food and Drug Administration (FDA) later issued a Class I recall, which is the most serious classification, recalling over 3,600 shoulder implant devices with product codes KWS and PAO and part number 115340. This is not the first recall for the Biomet, which was acquired by Zimmer in 2015. They have had two previous recalls, the first of which was in 2010.
Risks associated with the recalled shoulder implant include:
- Severe pain
- Permanent loss of shoulder function
- Infection
- Revision surgery
- Death
Although Zimmer-Biomet recalled their devices prior to the FDA’s warning, the notice did not recommend any specific monitoring instructions and only stated that surgeons should continue follow-protocols. The FDA Class 1 recall, however, informs patients and doctors that the use of these devices can cause either serious injury or death.
The Comprehensive Reverse Shoulder evaded some of the more rigorous clinical human trials other medical devices and drugs are required to endure by going through the FDA’s 510(K) fast-track program. The program allows medical device makers to avoid these tests if they can prove that their product is “substantially equivalent” to another approved device.
Seek Compensation for Your Injuries
If you are a patient who was harmed by Zimmer Biomet’s Comprehensive Reverse Shoulder implant, you may be able to seek compensation. At Brett H. Oppenheimer, PLLC our Kentucky personal injury attorney has more than 20 years of experience, and we have passionately advocated for the interests of countless clients. Manufacturers have a duty to their consumers to produce a product that will not cause them harm. When they fail to uphold that duty, risking your life and well-being, you have a right to take action against them.
Call us today at (502) 242-8877 for a free consultation.