Zimmer Biomet Reverse Shoulder Lawsuits

In shoulder replacement surgery, doctors replace the ends of the damaged upper arm bone (humerus) and usually the shoulder bone (scapula) or cap them with artificial surfaces lined with plastic or metal and plastic.

Reverse shoulder replacement surgery is a newer procedure used on people who have painful arthritis in their shoulder and also have damage to the muscles around the shoulder.

In a reverse shoulder replacement surgery, the surgeon removes the damaged bone and smooths the ends, he or she attaches the rounded joint piece to the shoulder bone and uses the cup-shaped piece to replace the top of the upper arm bone.

An estimated 90 percent of all shoulder replacements should last 10 years or more, so the FDA pays attention when implanted devices fail within just a few years of implantation, such as in the case of the Zimmer Biomet Comprehensive Reverse Shoulder System.

The Zimmer Biomet Shoulder Replacement was designed to restore arm movement to patients undergoing reverse shoulder replacement.

Zimmer Biomet received clearance for the Biomet Shoulder Replacement in 2008 through the controversial 510(K) program, an expedited clearance process that allows medical devices to go to market without the normal safety testing when the device maker can show that the new device is substantially similar to an already approved device.

On February 16, 2017, the FDA issued a Class 1 recall of the Zimmer Biomet Comprehensive Reverse Shoulder System.

The Class 1 recall is the most serious type of recall, reserved for devices that may cause serious injuries or death.

According to the FDA, the Zimmer Biomet Comprehensive Reverse Shoulder replacement devices fractures at higher rates than is stated on the label.

Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or death.

According to a May 2016 study of the Danish Shoulder Arthroplasty Registry between 2006 and 2012, fracture patients had a 6 times higher incidence of death within 30 days than the general population.

According to this study, pulmonary, cardiac, and abdominal causes of death were common.

2008:

• Zimmer Biomet received clearance for the Biomet Shoulder Replacement through the controversial 510(K) program.

2010:

• FDA Class II Recall of Zimmer Biomet Comprehensive Shoulder Humeral Tray with Locking Ring after receiving complaints regarding the fracturing of the device.

2016:

• Biomet settles with a Colorado man who filed a lawsuit for damages related to failure of his Comprehensive Reverse Shoulder Replacement.

December 20th, 2016:

• Urgent Medical Device Recall Notice sent by Zimmer to all affected customers.

February 16th, 2017:

• FDA Class I Recall of Zimmer Biomet Comprehensive Reverse Shoulder System.

Product liability lawsuits are currently being filed against Zimmer-Biomet alleging that the Comprehensive Reverse Shoulder Systems failed.

As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices.

In addition to revision surgeries, shoulder implant lawsuits allege that patients have been put at an increased risk for:

• Bone Loss
• Device Fracture
• Device Failure
• Permanent loss of shoulder function
• Infection
• Death