The Zimmer-Biomet Comprehensive Reverse Shoulder Humeral Tray (Model 115340) was supposed to help patients regain mobility often loss from rotator cuff injuries, arthritis induced arthropathy, or a previously failed shoulder joint replacement.
Less than a decade later, the FDA has recalled this device not once but twice, because many people are experiencing the device fracturing in high rates.
If you or a loved one had shoulder replacement surgery and your device fractured, we may be able to help you. Michael Brady Lynch is an experienced nationwide medical device attorney.
Contact us today for a free case evaluation so you can learn how we may be able to help.
About the Biomet Comprehensive Shoulder Implant
Doctors surgically implant the Comprehensive Reverse Shoulder Humeral Tray as a shoulder replacement device to help restore arm movement. Many patients received this device after either rotator cuff tears, arthritis induced arthropathy, or a previously failed shoulder joint replacement.
In 2007, the FDA approved the device under the 510(k) premarket program. Biomet only showed the new device was similar to others currently on the market. Unfortunately, this bypassed the need for rigorous clinical safety and efficacy studies to gain approval.
In 2010, Biomet pulled around 45 humeral tray and 45 locking ring components from distribution centers in 8 states. This is when they noted the first round of fracturing complaints. However, the FDA only labeled this recall as a Class II. This meant the device could cause temporary or reversible health consequences. The FDA halted the recall a year later.
The eight states involved in the recall were New York, Virginia, Maryland, Alabama, Colorado, South Dakota, Texas, and Oklahoma.
Recently, the FDA issued a Class I recall for the shoulder replacement device. They warn that use of the Biomet shoulder device may cause serious injury or death because the devices are fracturing at a higher rate than stated on the label. This class of recall is the most serious since there is a high probability the device will cause serious health issues or death. They urge doctors to monitor patients carefully with the recalled device.
The FDA estimated close to 4,000 people have the device.
Close to 50,000 Americans, get shoulder replacement surgery each year. They expect their device will alleviate their pain. Instead, many are facing horrific issues stemming from their device breaking apart. These include:
- Bone loss
- Malpositioning of the device
- Additional surgeries
If You Had Shoulder Replacement Surgery
So, if you had shoulder replacement surgery and your device fractured, contact us today. We will reach out to your doctor and find out if you have the recall device. Patients harmed by this device may be able to seek compensation for medical expenses, wages lost and other damages. Contact us today for a free consultation.
Speak to an Attorney Today
The FDA estimates doctors implanted over 4,000 people with Biomet’s faulty shoulder replacement device. If you or a loved one had a device fracture after your shoulder surgery, you need an attorney with experience helping people harmed by big corporations. The attorneys at the Michael Brady Lynch Firm know what it takes to go up against these manufacturers to get clients what they need.
How We Can Help
When you experience side effects, it can have devastating effects on your entire life. In fact, you may be entitled to compensation for their injuries and damages. The types of losses that can be recovered include:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Furthermore, if a person dies from complications, family members may be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Also, if a suit finds the conduct of a company in manufacturing and selling a product to be highly reckless, punitive damages may be awarded to punish the company and deter similar conduct in the future. If you developed a hernia reoccurrence after surgery, please speak to us to learn more about your rights.
Case evaluations are free of cost and without obligation. Therefore, call us today at (877) 513-9517 or contact us online to speak with an attorney about your options. We may be able to get you the help you need.