What is a Reverse Shoulder Replacement Surgery?
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.
Zimmer Biomet Comprehensive Reverse Shoulder System
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.
URGENT MEDICAL DEVICE RECALL ISSUED FOR PATIENTS IMPLANTED WITH ZIMMER BIOMET COMPREHENSIVE REVERSE SHOULDER REPLACEMENT SYSTEM
On December 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers. This Notice was directed mostly toward health care providers in an effort account for each of the 3,662 devices distributed between October 2008 and September 2015. But, it is important that consumers take note of this dangerous recall.
Any individual who received a total shoulder replacement between October 2008 and December 2016, should contact their healthcare provider immediately to determine if the Recalled Zimmer Biomet Comprehensive Reverse Total Shoulder Replacement Device was utilized.
FDA RECALL – Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate
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 in 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.
High Fracture Rate of Zimmer Biomet Shoulder System Could Lead to 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.
Zimmer Biomet Comprehensive Reverse Shoulder System Failure Lawsuits
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
Has There Been a Zimmer Biomet Shoulder Settlement?
In 2016, Biomet Inc. agreed to pay $350,000 to a Colorado man who claimed to experience failure of two Comprehensive Reverse Shoulder Replacement due to the component that the company had recalled in 2010.
According to court documents, the plaintiff underwent a left reverse shoulder replacement with Biomet’s Comprehensive Reverse Shoulder in September 2009, and the same device was implanted in his right shoulder in 2010. But within just a few years of implantation, both shoulders failed at the joint between the trunnion and the baseplate, causing the patient to experience pain, loss of function, and the necessity for revision surgery to remove and replace both devices.
Why File a Shoulder Replacement Lawsuit?
A shoulder replacement lawsuit may allow victims of failed shoulder replacement surgery to obtain compensation for their damages, which might include:
- Medical bills
- Lost wages
- Loss of enjoyment of life
- Pain and suffering
- Permanent injury
If you are a patient that had a Shoulder Arthroplasty and you suspect a fracture, contact your health provider immediately – close postoperative monitoring of pulmonary, cardiac, and abdominal conditions is important in fracture patients.
- 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.
- 12/20/2016 – Urgent Medical Device Recall Notice sent by Zimmer to all affected customers
- 2/16/2017 – FDA Class I Recall of Zimmer Biomet Comprehensive Reverse Shoulder System