At the time you consented to surgery, Zimmer Biomet’s Comprehensive® Reverse Shoulder System made sense. Many doctors in Kentucky have implanted patients with the shoulder replacement device.
This implant was meant to help restore your arm movement and to improve your quality of life. Unfortunately, that might not be what happened to you. Instead, you may be one of the people who was hurt by the Zimmer Biomet’s Comprehensive® Reverse Shoulder System, and you may be able to recover damages for the harm that you have suffered.
Reverse Shoulder Implant Recalled Due to High Rate of Fractures
According to the U.S. Food and Drug Administration (FDA), the Comprehensive Reverse Shoulder is fracturing at a rate that is higher than what is indicated as a risk on the product’s label. These fractures have led to painful and life-changing injuries, such as permanent loss of shoulder function and infection. In some cases, a fracture could even result in death.
Because of the serious risk of fracture, a class 1 recall of Zimmer Biomet’s Comprehensive® Reverse Shoulder System Humeral Tray Model 115340 was initiated on December 15, 2016. This recall of almost 4,000 devices includes all lot numbers with part number 115340 and product codes KWS and PAO. These devices were distributed between 2008 and 2015.
A class 1 recall is the most serious type of recall that can be issued by the FDA. The agency uses a class I recall when there is a reasonable probability that the medical product will result in serious injuries or death.
Do You Have a Fractured Shoulder Implant?
Many of the devices included in this recall are believed to have been implanted in Kentucky hospitals or surgical centers. If you have this implant, then you should speak directly with your doctor about the potential warning signs of a fracture and about what follow-up is recommended for you so that any problem can be diagnosed and treated quickly.
Potential signs of problems with the implant include:
- Loss of range of motion.
- Swelling and redness.
The signs of a fractured shoulder implant may be glaring or they may be subtle. Therefore, it is best to speak to your physician if you have been implanted with this device. If you are not sure if you have one of the recalled implants, our Louisville law firm can help you find out.
Problems With the Comprehensive® Reverse Shoulder System
Zimmer Biomet’s Comprehensive® Reverse Shoulder System did not go through the same rigorous safety review that many medical devices go through before gaining FDA approval. As with most medical devices that have failed and been recalled in recent years, this shoulder replacement device was approved via the FDA’s abbreviated approval process that companies use to get their product on the market as quickly as possible to begin making profits. Through this approval process, known as the 501(k) process, a medical device can be approved without a safety review if it is substantially similar to a product that already has FDA approval. Some of these devices have been on the market since 2007.
Problems began with the components of these devices within three years after they hit the U.S. market. Other recalls have been issued since the device came on the market. Specifically:
- Some humeral tray and locking ring components were recalled from distribution in eight states in September 2010. The reason for this recall was complaints that the device was fracturing after implantation. The FDA posted the class II recall in December 2010 and then terminated the recall in July 2011.
- Some Custom Comprehensive® Reverse Shoulder Humeral Trays were recalled in April 2011 because of locking rings that were incorrectly assembled.
Our firm has been investigating claims for failed shoulder implants in Kentucky since 2010, and we will continue to do so to help anyone who has been hurt.
Lawsuits for Recalled Shoulder Replacement Devices in Kentucky
Biomet has already settled a lawsuit alleging a fracture injury from its Comprehensive® Reverse Shoulder System. The plaintiff allegedly had two Comprehensive® Reverse Shoulder Systems implanted that fractured and caused him to undergo further surgeries. That case reportedly settled in February 2016 for $350,000. Many other lawsuits have been filed across the country concerning the Biomet Comprehensive® Reverse Shoulder System.
If you have been seriously injured by a Zimmer Biomet shoulder implant, get the information you need to make an informed decision about your future.
Contact our Kentucky medical device injury lawyers for a free, no-obligation consultation by calling 888-450-4456.
Don’t go up against the pharmaceutical company alone. Their goal is not to provide you fair compensation if you are hurt by its product. Instead, it has professionals working hard to maximize the company’s profits by paying you as little as possible for your injuries. At Gray & White, our experienced legal team includes a staff nurse and we will spare no expense to make sure that your right to fair compensation is protected.