A Class 1 recall of Zimmer Biomet’s Comprehensive Reverse Shoulder System has been announced by the U.S. Food and Drug Administration (FDA) in February. A Class 1 recall indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The Comprehensive Reverse Shoulder System is a shoulder replacement device. The device is made to be surgically implanted to restore arm movement in individuals with rotator cuff tears who have developed arthropathy (a severe type of shoulder arthritis) and have failed shoulder joint replacements, MassDevice reports.
What is a Reverse Shoulder Replacement?
Reverse shoulder replacements are made so that the ball and socket of the shoulder joint are reversed with the ball of the joint being implanted to the shoulder socket of the scapula and the socket of the joint is implanted at the top of the humerus (arm bone). This system relies on the deltoid (one of the stronger shoulder muscles) muscle group to hold the joint in position. The idea is that a reverse shoulder implant will help restore motion to patients who have lost mobility in their shoulders.
The surgery to implant this type of device is exceedingly technical and the devices used in this type of procedure can cause serious complications if the components wear, dislocate, or loosen. In such cases, the patients must be re-operated on so the device may be repaired, replaced, or removed.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits regarding medical devices. The firm offers free, no-obligation case evaluations for individuals seeking legal information for a potential lawsuit.
Reason for the Class 1 Recall
The system is being recalled because it has been found to be fracturing at a higher rate than stated in the labeling, said the FDA. The fractures may call for revision surgeries, which may cause permanent loss of shoulder function, infection, or death, according to the agency.
For some individuals, the risks of additional surgeries are too great, leaving patients with defective implants, while for others the damage caused to local tissue and bone may prevent a patient from being a revision candidate.
A total of 3,662 devices is being recalled by the company with product codes KWS and PAO and part number 115340, manufactured between August 25, 2008 and September 27, 2011. Distribution dates affected are between October 2008 and September 2015.
The Warsaw, Indiana-based company began sending recall notices for the devices on December 20, 2016 including instructions for quarantining and returning affected devices.
Previous Lawsuit Involving Biomet
A plaintiff underwent a left reverse shoulder replacement with Biomet’s Comprehensive Reverse Shoulder in September 2009. The same device was implanted in his right shoulder in 2010. But, within just a few years of implantation, both shoulders failed, causing pain and loss of function. As a result, the plaintiff was forced to undergo revision surgery to remove and replace both devices.
The lawsuit was slated to go to trial in the District of Colorado in February 2016. It is reported that the case was settled for $350,000. It is believed that this amount reflects the serious pain and injury caused by the Zimmer-Biomet Comprehensive Reverse Shoulder System.
The Biomet Comprehensive Reverse Shoulder device was approved in 2007 by the FDA under the controversial 510(k) premarket program. This allows Biomet only had to show that its new device was “substantially similar” to others currently on the market. This fast-track process allows the manufacturer to bypass the need to submit stringent clinical safety and efficacy studies for FDA approval.
Treatment of Bone Marrow Lesions
In early February, Zimmer-Biomet won CE Mark (Compliance with European Directives) approval in the European Union for its Subchondroplasty procedure designed to treat subchondral bone marrow lesions (BMLs), reports MassDevice.
Causes for bone marrow lesions (BML) are not specifically known, but may be a stress reaction that forms from overuse of the joint, excessive loading of the joint, or poor mechanics. Obesity and poor diet are a possible contributor increasing the likelihood of developing BML. It is found more commonly in middle-aged patients rather than younger patients. Patients with poor alignment are more likely to develop BML.
Legal Advice and Information for Medical Device Issues
If you or someone you know suffered injuries associated with the use of a medical device, you may have valuable legal rights. Parker Waichman personal injury lawyers are available to answer any questions you may have. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).