Zimmer Biomet Shoulder Lawsuit
A Zimmer Biomet shoulder lawsuit may be an option for patients who experienced complications associated with the recalled shoulder replacement devices. Manufactured by Zimmer Biomet, Inc., the Comprehensive Reverse Shoulder is a surgically-implanted shoulder replacement device used to help restore arm movement. However, the devices have been linked to high fracture rates, which could lead to permanent loss of shoulder function, infection, or in rare cases, death. Affected patients and their families may be able to file a lawsuit and recover compensation with the help of a defective medical device attorney.
If you or a loved one is experiencing problems with a shoulder replacement, contact Attorney Group for information on your options. We offer free, confidential consultations, without any obligation on your part. If you choose to pursue a claim, we can connect you with an affiliated Zimmer Biomet shoulder lawsuit attorney who can assist you throughout the legal process.
Have You Seen a Zimmer Biomet Shoulder Lawsuit Commercial?
You may have seen a Zimmer Biomet shoulder lawsuit commercial on television and wondered whether you or a loved one have been affected by a Zimmer Biomet Comprehensive Reverse Shoulder System and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is the Comprehensive Reverse Shoulder System?
When medications and other treatments such as physical therapy are no longer able to help alleviate pain associated with a shoulder joint, shoulder replacement surgery may be useful to help a patient regain mobility and resume their daily activities.
The Comprehensive Reverse Shoulder is a surgically-implanted shoulder replacement system manufactured by Zimmer Biomet, Inc., a medical device company that designs, develops, manufacturers and markets orthopaedics products.
Comprehensive Reverse Shoulder Systems are designed to help restore arm movement in patients with severe shoulder fractures as well as other complications affecting the shoulder joint.
Reverse shoulder replacement devices can be beneficial for patients with rotator cuff tears who have developed arthropathy, a severe type of shoulder arthritis, as well as previously failed shoulder joint replacements.
A conventional shoulder replacement system uses the rotator cuff to function properly, and those muscles no longer function in patients with a large rotator cuff tear and cuff tear arthropathy.
Patients who experience “cuff tear arthropathy” often require a reverse total shoulder replacement instead of a traditional shoulder replacement because conventional shoulder replacement surgery may result in added pain and limited motion.
Reverse Total Shoulder Replacement Risks
According to the American Academy of Orthopaedic Surgeons, thousands of people in the United States have shoulder replacement surgery each year. While the number of patients who undergo shoulder replacement surgery is much smaller than those who have knee replacement surgery, shoulder surgery can often be effective in relieving shoulder joint pain.
Reverse total shoulder replacement can be a highly technical surgical procedure. Complications and risks associated with reverse total shoulder implants include:
- Loosening of the device
- Nerve injury and damage
Should one of these complications arise, revision surgery or additional operations may be necessary to repair the shoulder joint.
According to the FDA, fractures caused by a Zimmer Biomet Comprehensive Reverse Shoulder System may cause patients to have revision surgeries, which may lead to other health consequences, including permanent loss of shoulder function, infection, or in rare cases, death.
Zimmer Biomet Shoulder Recall
Zimmer Biomet has notified health care providers performing reverse shoulder replacement surgery and patients receiving total shoulder replacements that it is recalling certain model numbers of their Comprehensive Reverse Shoulder System due to a higher fracture rate than stated on the device’s label.
According to a recall notice issued by the FDA, 3,662 Comprehensive Reverse Shoulder Systems manufactured from August 25, 2008 to September 27, 2011, are included in the recall. The FDA’s recall notice contains a full list of lot numbers.
A Zimmer Biomet sales representative will remove any affected device from facilities using the devices. In addition to existing surgical follow up protocols, the FDA reports that there are no specific patient monitoring instructions related to the recall.
Initially recalled on December 15, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form asking all affected customers to:
- Review the safety notice sent to customers in December 2016
- Identify and quarantine any affected devices in stock
- Complete and return the Certificate of Acknowledgement form
- Retain a copy of the Certificate of Acknowledgement form for records
The FDA has identified this recall as a Class I recall, the most serious type of recall. Use of these devices may lead to serious injury or even death.
Other Zimmer Biomet Recalls
In April 2011, Zimmer Biomet issued a shoulder replacement recall for Custom Comprehensive Reverse Shoulder Humeral Trays. According to the recall notice published by the FDA, some of the Humeral Trays may contain a locking ring that is incorrectly assembled.
In 2010, three years after the Comprehensive Reverse Shoulder was approved by the FDA, Zimmer Biomet recalled the humeral tray and locking ring components of the system. The company reportedly initiated the recall after receiving complaints that the device was fracturing after being implanted. The FDA labeled the recall as a Class II recall, meaning that the use of the device could cause temporary or reversible adverse health consequences. The recall was terminated in July 2011.
Is There a Zimmer Biomet Shoulder Class Action?
There is no Zimmer Biomet Shoulder class action pending as of March 2017. Zimmer Biomet Shoulder lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the device. Instead, if multiple Zimmer Biomet Shoulder lawsuits are filed against the device manufacturers alleging injuries and other damages caused by a Zimmer Biomet Comprehensive Reverse Shoulder System and similar devices, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding. MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by defective medical devices.
Have There Been Zimmer Biomet Shoulder Settlements?
In February 2016, Zimmer Biomet reportedly agreed to settle a lawsuit involving its Comprehensive Reverse Shoulder System for $350,000. According to court documents, the plaintiff underwent two total reverse shoulder replacement surgeries in his left and right shoulders with the Zimmer Biomet Comprehensive Shoulder System in 2009 and 2010, respectively. Within just a few years after the devices were implanted, both shoulders allegedly failed at the joint, requiring the plaintiff to undergo revision surgery to remove and replace the implants.
The outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes. If a settlement is reached, however, it generally does not affect another patient’s right to bring his or her own individual case.
Zimmer Biomet Shoulder Lawsuit News
- February 2017FDA issues recall notice to the agency’s 2017 Safety Alerts for Human Medical Products web page.
- December 2016Zimmer Biomet recalls certain model numbers of its Comprehensive Shoulder system. According to the recall notice issued by the FDA, the devices may cause a higher rate of shoulder fracture than previously thought, which may lead to other severe health consequences.
- December 2016Zimmer Biomet sends Urgent Medical Device Recall Notice and Certificate of Acknowledgement form to all affected patients.
- April 2011Zimmer Biomet issues a shoulder replacement recall for Custom Comprehensive Reverse Shoulder Humeral Trays because the trays may contain a locking ring that is incorrectly assembled.
- September 2010Zimmer Biomet initiates Class II recall for its Comprehensive Reverse Shoulder Humeral Tray with Locking Ring due to the device’s potential to fracture and lead to other complications.
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Zimmer Biomet Shoulder Lawsuit Claims
A Zimmer Biomet Shoulder lawsuit may be filed on behalf of patients who claim to have suffered serious injuries and other damages as a result of fractures, infections or other complications following reverse total shoulder replacement surgery. The amount of time you have to pursue a claim is limited. It is important that you speak with an affiliated shoulder recall lawyer to learn more about the time you have to pursue a claim for compensation.
How a Zimmer Biomet Shoulder Lawsuit Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a medical device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Bair Hugger warming blankets may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.