Shoulder replacement surgeries are performed on joints that are so damaged they need a prosthesis device replacement. Some procedures involve replacing the ball of the humerus bone, while other procedures replace both the ball and the socket. If the patient needs a total shoulder replacement, surgeons will implant a humeral device, but there must be healthy bone material in the area of the implant.
During the procedure, the surgeon will attach the metal or ceramic device with cement-free anchorage. Unfortunately, many of these devices begin to fail over time and the implant itself can become loose or fracture. If this occurs, the only choice the patient has it go through another surgery where the damaged implant is removed and replaced with another one.
In 2008, Biomet, Inc. (later purchased by Zimmer Holdings) developed a shoulder replacement device that was approved by the Food and Drug Administration (FDA) without any human clinical trials done. This fast-track approval would later backfire when the FDA issued a recall for all devices that were manufactured from August 25, 2008 through September 27, 2011. The mandatory FDA recall came two months after Zimmer Biomet issued a voluntary recall in December 2016.
According to the company, these devices were distributed and used from October 2008 through September 2015. The recall was a result of numerous complaints filed by patients who suffered shoulder fractures from the device. These fractures caused many complications including infections, severe and chronic pain, and permanent loss of the use of the shoulder.
The FDA recall was not the first time the company had shoulder replacement device recalled. In September 2010 and April 2011, the company had two other devices recalled because of issues with fractures and incorrect assembly of the product.
The defective design of the shoulder implant devices has a high rate of fractures in patients. These fractures cause a myriad of serious to severe complications that may have been avoided if there was more oversight and testing of the product before it was approved. Complications include:
The advice of the FDA to doctors was to just monitor patients who have the devices, despite the high fracture rate. The defective device has resulted in many lawsuits. If you have suffered a fracture and/or other complications from your shoulder replacement device, contact a defective product attorney to find out what legal options you may have.
For more information about shoulder implant failures lead to recalls and lawsuits, call the Saavedra Law Firm today.