Zimmer Biomet Shoulder Implants Fracturing and Failing at High Rates
In February, 2017, the U.S. Food and Drug Administration (FDA) issued its highest level recall for the Zimmer Biomet Comprehensive Reverse Shoulder System. The device has been found to have a high fracture rate and require a higher rate of revision surgeries as a result. An FDA class I recall is reserved for potentially the most dangerous devices on the market, which may cause serious injury or death.
When an artificial joint fractures, a patient must undergo revision surgery. Any major revision surgery comes with serious risks: infection, excessive bleeding, losing function in the joint, and even death.
However ingenious the concept of a reverse shoulder replacement, the Zimmer Biomet design is flawed and has caused numerous injuries. Zimmer Biomet has admitted the problems are due to the device’s design, rather than a manufacturing error. The FDA announced in their recall report that the rate of post-implant fractures seen with these shoulder systems is much higher than what is stated on the device’s label.
Zimmer Biomet recalled over 3,600 Comprehensive Reverse Shoulder Replacements due to a high risk of fracture, revision surgery, and devastating complications like infections, disability, or death. The U.S. Food and Drug Administration (FDA) designated it a Class I recall the most serious type of recall, indicating the implanted devices may cause serious injuries or death.
The FDA stresses that there are unique problems with reverse shoulder surgery. Loosening, instability, and fracture of the baseplate are ongoing issues that device manufacturers have tried to fix with locking screws. However, studies continue to show high rates of infection, nerve damage, and hematoma.
Any prior patient with a Zimmer Biomet Comprehensive Reverse Shoulder Replacement system should contact their surgeon immediately. Defective implant issues may require extensive and painful revision surgery.
Joe Lyon is a highly-rated Cincinnati product liability lawyer and Ohio medical device lawyer representing plaintiffs nationwide in a wide variety of civil litigation claims.
Shoulder Replacement Fracture & Failure
The Zimmer Biomet Reverse Shoulder is an artificial shoulder joint that is used to restore mobility and to reduce pain. The Comprehensive Reverse Shoulder is marketed by Zimmer Biomet to individuals with rotator cuff tears, patients who have developed severe shoulder arthritis, or patients who have previously received failed shoulder joint replacements.
Artificial joints can bring relief to patients with injuries and damaged joints, and can also restore mobility and flexibility, but there are also major risks and complications.
The Comprehensive Reverse Shoulder system is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears and those who have developed severe types of shoulder arthritis. Reverse shoulder surgery switches the “ball-and-socket” in the shoulder, replacing the shoulder socket with a metal ball, and cutting off the top of the arm bone and attaching a plastic cup.
The defective Biomet devices were manufactured from August 25, 2008 to September 27, 2011, and were distributed from October, 2008 to September, 2015.
Zimmer Biomet sent an Urgent Medical Device Recall Notice on December 20, 2016 to warn surgeons that some Comprehensive Reverse Shoulder Systems are fracturing at a higher rate than expected. The company asked customers to “identify and quarantine” the failing devices.
Complications of Defective Shoulder Implant
The U.S. Food and Drug Administration (FDA) has warned that certain patients with defective shoulder devices may experience painful and debilitating side effects, including the following:
• Severe pain
• Implant fracture
• Adverse tissue (allergic) reactions
• Joint instability
• Nerve damage
History of Defective and Failing Biomet Devices
This is not the first time Zimmer Biomet has recalled defective shoulder implants. In fact, the company has recalled failing devices several times in the past, establishing a dangerous safety record.
- Biomet issued two previous Class II recalls for the Comprehensive Reverse Shoulder, including one recall in September, 2010 that was again due to fractures. The other recall in April, 2011 was due to an assembly error.
- In January 2015, Biomet initiated a recall of its Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor.
Patients implanted with a Zimmer Biomet Shoulder Replacement system should consider contacting their implanting surgeon if they suffer from any of the above symptoms.
Zimmer Biomet & Defective Medical Devices
This would not be the first time Zimmer Biomet has marketed defective devices to the public. The company has settled several lawsuits over a defective artificial hip system. As in the recalled shoulder implant device, the faulty hip led to higher rates of revision surgery in patients, and it was recalled in 2008.
Medical device companies are known to put profit before safety, and release products before they are proven to be safe. The recalled Comprehensive Reverse Shoulder was brought to market via the FDA’s 510(K) program, which allows a medical device manufacturer to forgo clinical trials if they can demonstrate that a product is “substantially equivalent” to another device that is already FDA-approved.
Perhaps the device is similar to others, but it is defective, and on December 20, 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice regarding certain Comprehensive Reverse Shoulder Systems. The FDA recall came a couple months later.
Flawed Design Leads to Patient Injuries
Reverse total shoulder replacements are known to have a complication rate of four times that of conventional total shoulder replacement surgery. In a conventional shoulder replacement system, a ball is attached to the upper arm and a cup in the socket to make a ball-and-socket joint. In a reverse shoulder system, the artificial joint attaches the cup to the upper arm and the ball to the socket. This reversed system of the Zimmer Biomet Shoulder Implants is said to function better for patients with large rotator cuff tears.
Though less common than conventional total shoulder replacement, thousands of reverse total shoulder replacements are implanted in the U.S. each year. This recalled model was used in thousands of surgeries across the country over the last seven years.
Zimmer Biomet Shoulder Implant Defects
The reason the latest Zimmer Biomet recall is categorized as a Class 1—the highest level possible—is because the FDA has determined that there’s “a reasonable probability that use of these products will cause serious adverse health consequences or death.” Patients with failing and fractured reverse shoulder implants must go through additional surgery to fix the problem, which can lead to several secondary issues, such as permanent loss of shoulder function, infection, or even death.
Recipients of the Comprehensive Reverse Shoulder who experience a failure or fracture related to this recall may be entitled to compensation. Because the risk of fracturing is greater than the company warned in its device labeling, victims are holding Zimmer Biomet accountable and working with experienced product liability attorneys.
Defective Zimmer Biomet Shoulder Implants
Patients who have received a Zimmer Biomet Comprehensive Reverse Shoulder Replacements system should talk with their implanting surgeon, especially if they are experiencing pain, or other post-operative complications.
The FDA approval process for medical devices is dangerous and far too lenient. As a result, many of Biomet’s defective products like fracturing shoulder implants injure American consumers. Injured patients and experienced attorneys have a duty to force large medical device companies like Zimmer Biomet to claim responsibility for the defective products they market and distribute.
If you or a loved one have received a defective Zimmer Biomet shoulder implants, and have questions about the legal remedies available to improve quality of life and medical care in Ohio, contact The Lyon Firm at (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer critical questions regarding Zimmer Biomet Shoulder Implants.