Reverse Shoulder Replacement
One type of shoulder surgery, known as reverse shoulder replacement, is a surgical procedure that reverses the normal anatomy of the shoulder. The deltoid muscle, one of the stronger shoulder muscles, is given control to raise the arm. A reverse shoulder implant can help restore motion to patients who have lost mobility in their shoulders.
The Comprehensive Reverse Shoulder by Zimmer Biomet is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
FDA Class I Recall: High Fracture Rate
February 15, 2017, the FDA announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implant because these devices are fracturing at a higher rate than stated in the labeling.
Complications may include:
- Bone loss
- Device failures, fractures and malpositioning
- Instability and weakness
Fractures may result in serious pain and force you to have revision surgery to remove or replace the device. As with all revision surgeries, there is an increased risk of suffering serious adverse health consequences such as permanent loss of shoulder function, infection or possibly death.
Zimmer Biomet initiated the recall of this implant on December 20, 2016 when it sent an Urgent Medical Device Recall Notice to affected customers.
The recall notice alerted doctors and healthcare facilities that the implant should not be used and that Zimmer Biomet would collect any existing devices. The notice instructed doctors to continue monitoring patients implanted with the recalled device but provided no additional patient monitoring instructions.
FDA Market Approval
Biomet Zimmer’s Comprehensive Reverse Shoulder implant was approved for use in 2007 under the FDA’s 510(k) premarket program.
What this means is that Biomet Zimmer only had to show that the device was “substantially similar” to others currently on the market. This process allows a manufacturer to bypass the need to submit rigorous clinical safety studies for FDA approval.
The FDA uses a risk-based, tiered approach for regulating medical devices, classifying them as either Class I, II or III. The class a medical device is assigned determines the type of premarketing submission/application required for FDA clearance to market.
Moderate risk medical devices are typically cleared for marketing based on an FDA determination that they are substantially equivalent to an already legally marketed device of the same type.
Shoulder Replacement Lawsuits
Patients who have suffered a shoulder replacement failure claim the devices failed to adequately warn consumers or doctors of the risk of fracturing.
Biomet has already settled a lawsuit involving its Comprehensive Reverse Shoulder System for $350,000. The Plaintiff was implanted with two devices, one in each shoulder, that later fractured. The man had to undergo additional surgeries to remove and replace the devices.
Receive a Free Evaluation from Experienced Attorneys
Defective joint replacement lawsuits are often complicated. You need experienced attorneys who know how to navigate the system, the ins-and-outs of medical lawsuits and joint replacement litigation. The highly-experienced attorneys at Nash & Franciskato have a long track record of successfully litigating defective orthopedic cases.
If you were implanted with a defective Comprehensive Reverse Shoulder by Zimmer Biomet that requires revision surgery, contact us today for a free, no-obligation case evaluation.