Biomet Shoulder Recall Lawsuit | Biomet Reverse Shoulder Recall Lawsuit
Biomet Shoulder Recall Lawsuit | Biomet Reverse Shoulder Recall Lawsuit | Biomet Shoulder Replacement Recall Lawsuit | Biomet Reverse Shoulder Recall Lawsuit Attorney
The attorneys at Southern Med Law are investigating Biomet Shoulder recall lawsuit filings and the potential for compensation to patients who have been injured after complications from the Biomet Reverse Shoulder System. The look into shoulder replacement failure lawsuits comes after Zimmer Biomet issued a recall of 3,662 Comprehensive Reverse Shoulder System Humeral Tray devices due to a high fracture rate. In February, the U.S. Food and Drug Administration (FDA) identified the Biomet Reverse Shoulder recall as Class I, the agency’s most serious type of recall, because use of these reverse shoulder systems may cause serious injuries or death. Zimmer Biomet notified patients and health care providers about the should replacement system recall in December.
Biomet Reverse Shoulder Complications
According to Zimmer Biomet, fractures in the Comprehensive Reverse Shoulder devices may result in implant patients suffering such adverse health issues as:
- Permanent loss of shoulder function
Biomet Shoulder Recall
Zimmer Biomet is recalling all lot numbers of the titanium Comprehensive Reverse Shoulder System Humeral Tray Model 115340. The recalled devices were manufactured between August 25, 2008 to September 27, 2011 and distributed from October 2008 to September 2015. Zimmer Biomet gave no specific patient monitoring instructions other than following up with their surgeons.
[http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm541862.htm, February 16, 2017]
Biomet Shoulder Replacement Recall Lawsuit
Dr. Blaudeau and the medical device attorneys at Southern Med Law is investigating claims from patients who received the titanium Comprehensive Reverse Shoulder System Humeral Tray Model 115340. If you have been harmed by the recalled shoulder replacement device, you may be eligible for compensation for your injuries. Southern Med Law has years of experience in handling medical device injury lawsuits. The firms attoneys’ know how to best handle your claim. To speak to one of the firm’s Biomet Shoulder Replacement Recall Lawsuit attorneys, please call 205-547-5525 or for more information visit www.southernmedlaw.com.
The FDA And Biomet’s Comprehensive Reverse Shoulder System
The Biomet Comprehensive Reverse Shoulder System received 510(k) clearance from the FDA in 2008. The federal agency’s 510(k) program does not require medical device manufacturers to conduct human clinical trials with their new products if the devices are shown to be “substantially equivalent” to another FDA-approved device that is already being sold. According to the FDA, Biomet has undergone two previous recalls of its Comprehensive Reverse Shoulder devices:
- The Comprehensive Reverse Shoulder Humeral Tray with Locking Ring was recalled in September 2010 due to complaints over the fracturing at the joint between the trunnion and the baseplate.
- Custom Comprehensive Reverse Shoulder Humeral Trays were recalled in April 2011 because certain units may have contained a locking ring that was incorrectly assembled.
The FDA identified these recalls as Class 2 which are not as severe as a Class 1 recall.
Biomet Comprehensive Reverse Shoulder System
The Comprehensive Reverse Shoulder helps restore arm movement and is beneficial particularly for people with rotator cuff tears who suffer pain due to arthropathy, a severe type of shoulder arthritis or patients who previously had a failed shoulder joint replacement. According to the American Academy of Orthopaedic Surgeons (AAOS), reverse shoulder replacement involves switching the socket and metal ball, which means a “metal ball is attached to the shoulder bone and a plastic socket is attached to the upper arm bone.” The switch allows the patients to use the deltoid muscle instead of the torn rotator cuff to lift the arm, the AAOS said.
Biomet Shoulder Replacement Recall Lawsuits
Patients in Biomet Shoulder Replacement lawsuits state they suffer pain due to failure of the medical devices. In 2016, Biomet settled a shoulder replacement lawsuit for $350,000. The complaint was filed on behalf of a Colorado man who received a left reverse shoulder replacement in 2009 and a right should replacement the following year. The plaintiff had to eventually undergo two surgeries to remove the failed devices, according to the shoulder replacement lawsuit. The plaintiff was implanted with components that were a part of the 2010 Biomet shoulder replacement recall, the complaint said. (Zimmer Biomet Shoulder Replacement Lawsuit No. 14-2667, U.S. District Court, District of Colorado)
About Southern Med Law And Filing A Biomet Shoulder Recall Lawsuit
Southern Med Law, led by Dr. François Blaudeau, an attorney and a practicing Doctor, has a deep understanding of the complex medical and legal questions at issue in the Biomet Reverse Shoulder Replacement recall. They are not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success. To speak to one of the firm’s Biomet Shoulder Recall Lawsuit attorneys, please call 205-547-5525 or fill out the online form.