Zimmer Biomet Recalls Shoulder Device with High Fracture RateMar 17, 2017
People who have had shoulder replacement surgery to restore arm movement may want to ask their surgeon what shoulder device was used. The Zimmer Biomet Comprehensive Reverse Shoulder System has been recalled because of a high fracture rate.
Zimmer's Comprehensive Reverse Shoulder System Humeral Tray Model 115340 was designed to be surgically implanted in patients with rotator cuff tears who developed a severe type of shoulder arthritis known as arthropathy. The device was also used as a replacement for previously failed shoulder joint implants.
If the device fails, the patients would experience significant shoulder pain, a loss of function of their shoulder and arm, or an infection might develop. The patient might experience a sudden fracture that would be obvious and dramatic. A patient with a failed Zimmer Biomet shoulder device would need revision surgery-surgery to remove and replace the device.
The experienced device injury attorneys at Parker Waichman can offer advice to individuals who face shoulder revision surgery or who have had such surgery because of a fractured Zimmer Biomet Comprehensive Reverse Shoulder System.
A patient undergoing revision surgery again faces all the potential risks of surgery, including pain, infection, and allergic reactions to drugs. Revision surgery may be more painful and difficult than the original shoulder replacement because of damage to bone and tissue caused by the failed device. The patient has to go through another recovery period, with time missed from work and family responsibilities. Additional physical therapy is needed to rebuild strength and regain range of motion in the joint. The repeat surgery will likely have an impact on the family members, who must provide help and care as the patient recovers and take on extra responsibilities during the patient's recovery period. The revision surgery occurs under less favorable conditions than for the original surgery, and so the outcome may not be as good as the original joint replacement, leaving the patient with permanent limitations.
Class I Recall
Biomet initiated the recall of 3,662 of the Comprehensive Reverse Shoulder device in December 2016. In the recall letter, the company advised customers to remove any of the recalled shoulder devices from inventory and quarantine them until they can be returned to Zimmer. The recalled Zimmer Biomet shoulders were manufactured from August 25, 2008 to September 2011. A full list of lot numbers is available in the Recall Notice on the FDA website.
The U.S. Food and Drug Administration (FDA) has designated the Zimmer Biomet recall as a Class I recall, the most serious recall category. There is a risk of serious injury or death.
In light of the recall, many patients have serious concerns about the safety of the Zimmer Biomet shoulder devices. Patients want to know when Zimmer Biomet became aware of the high rate of fractures and how quickly the device maker acted to initiate the recall. Thousands of patients have brought lawsuits against the makers of knee and hip replacement devices because these devices proved defective and caused significant injuries and complications. Many of the lawsuits have alleged that the device makers did not adequately warn doctors and patients of the risks. At trial, plaintiffs' attorneys have presented evidence that device makers concealed what they knew about a device's defects or ignored mounting reports of injuries and complications. There is a tension between the desire to speed the process of bringing devices to market and the need to assure the safety and effectiveness of those devices.
The Comprehensive Reverse Shoulder was introduced to the market under the FDA's 510(k) program, an expedited device approval pathway. Manufacturers may skip human clinical trials if the manufacturer can show that device or product is "substantially equivalent" to a similar device that the FDA approved previously. The process has been criticized because substantial equivalence does not guarantee that a device will function in the way the previously approved device.
Manufacturers and patients have learned hard lessons about the safety and effectiveness of devices. Small differences in materials or design can make big difference in how a device function. Critics of 510 (k) say that every device needs clinical testing to demonstrate its safety and effectiveness.
Legal Help for Patients with a Zimmer Biomet Shoulder Implant
If you or someone you know has a Zimmer Biomet Comprehensive Reverse Shoulder implant and has needed revision surgery, you may have important legal rights. To contact the device-injury attorneys at Parker Waichman LLP for a free, no obligation case evaluation, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).