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CASE UPDATE: Class I Recall of Zimmer Biomet Shoulder Replacement Device Issued
February 2017 – Zimmer Biomet, an Indiana-based medical device company specializing in shoulder replacement implant devices, has recently had to recall more than 3,000 of their artificial shoulder replacement implants. Increased rates of medical device reports, suggesting that the implants have a high likelihood of post-op fracturing, lead the FDA to initiate this Class I recall. A Class I recall is the most serious recall issued by the FDA indicating a serious risk of serious injuries or even death.
The Biomet Comprehensive Reverse Shoulder replacement device will fracture inside the patient's shoulder, leaving the patient with little-to-no shoulder motor function and a risk of continued injury. To resolve the issue, healthcare practitioners have had to resort to post-operational surgical correction, an invasive process that can lead to potential harms including "permanent loss of shoulder function, infection, or rarely, death" as explained by an FDA report.
According to reports from Zimmer's recall, the issue seems to stem from a malfunction in the Comprehensive Reverse Shoulder device's "humeral tray", a composing piece that has a tendency to break away from the device. According to Zimmer, their product does carry a consumer warning label. However, the company has stated, "the devices are fracturing at a higher rate than is stated in the labeling."
The company first issued the recall in December 2016, urging healthcare institutions to "quarantine" all remaining Comprehensive Reverse Shoulder replacement devices. There are nearly 3,660 devices still on the market that Zimmer is still working to recover.
This is the second time that the same device has been pulled from the market. The first recall occurred in 2010 when Biomet, which has since been bought out by Zimmer, was forced to pull their Comprehensive Reverse Shoulder replacement device from the market due to the high reports of post-op fracturing. Just like the current product, it was the device's humeral tray that had a tendency to break away from the device after surgery.
Neither Zimmer nor the FDA has issued statements on how they plan to address serving the patients who have already received the recalled devices.
In shoulder replacement surgery, a device is surgically implanted into the shoulder to repair complex fractures, restore range of motion in a patient who suffers from rotator cuff deficiencies, and/or alleviate pain. The overall goal of the device is to improve arm movement. Although less common than the total shoulder replacement, the reverse shoulder replacement device is used in thousands of surgeries a year in the United States.
Shoulder replacement surgeries are often performed on patients who have either already undergone a previous shoulder replacement surgery that failed or has large rotator cuffs that caused them to develop arthropathy.
Often times, patients are not aware of the specific brand of device used in surgery. If you received a reverse shoulder replacement between 2008 and 2015, contact your doctor and/or surgeon for additional information about the device used. The device you received may qualify for a shoulder replacement lawsuit.
While intended to restore the function of the shoulder and increase flexibility, the Smith and Nephew PROMOS Modular Shoulder System has been subject to a Class 2 device recall. Similar to their competitors, Smith and Nephew, a medical technology business with more than $4.9 billion in annual sales, is facing controversy as their shoulder replacement device is defective and has caused injuries in patients. According to the FDA, “the device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis.” But, the manufacturer has received complains of Inclination Set Screws fracturing.
Issued on January 14, 2010, shoulder replacement devices implanted prior to the recall date will need to be replaced. Sales representatives for the manufacturer were “instructed to immediately quarantine the product for return” to Stericycle, a regulated waste disposal and compliance solutions company. TorHoerman Law is now investigating fracturing claims. If you have been injured as a result of the Smith and Nephew shoulder replacement device, please contact our office.
Zimmer Biomet Comprehensive Reverse Shoulder Replacement devices were introduced to the market in 2008 by Zimmer Biomet, a medical technology manufacturer based in Indiana. Since then, a recall of more than 3,500 of the products manufactured between 2008 and 2015 has been issued. The recall of the device is due to the reports the humeral tray in the device is fracturing at a much higher rate than previously indicated and could cause injuries or death. The fractures may result in a corrective surgery that could increase the likelihood of serious health consequences such as permanent loss of shoulder function, infection, or death.
The recall is a Class I – the highest category. According to the FDA notice, this recall is noted to have a “reasonable probability that use of these products will cause serious adverse health consequences or death.” The notice did not suggest specific instructions for patients but instead urged doctors to proceed with surgical follow-up protocols.
The fracturing of a shoulder replacement device causes the device to become loose within the shoulder. The fracturing of the device can cause severe pain and discomfort, loss of shoulder function, or even revision surgery.
TorHoerman Law is currently pursuing cases with the following injuries:
If you have had complications as a result of a shoulder replacement device, please contact a TorHoerman Law to discuss your options.
If you think you have a potential case against either manufacturer and their shoulder replacement devices, we would be happy to talk. TorHoerman Law offers free, no-obligation case evaluations.
We have a dedicated team of shoulder replacement lawyers who will be here to help you every step of the way. Our firm is a nationwide products liability firm that wants to help those suffering from a personal injury due to dangerous and defective medical devices, and by representing you, we will do so to the best of our ability.
December 2016 – The medical device manufacturer, Zimmer Biomet, sent an Urgent Medical Device Recall Notice and Certificate of Acknowledgement to all customers, mostly health care providers to account for the thousands of devices used in patients between October 2008 and September 2015.
February 2016 - The first individual settlement has been reached for one man suffering adverse health effects from Zimmer's hazardous device. The case, coming out of the U.S. District Court of Colorado, was filed in 2014 and has finally been resolved more than two years after.
The plaintiff had originally received two separate Comprehensive Reverse Shoulder replacement devices to fix a rotator cuff tear in one arm and severe arthritis in the other. After receiving the implants, both devices fractured, causing the plaintiff high levels of pain and a major loss of motor functions in both arms.
The plaintiff claimed that Biomet had kept the device in the market despite being fully aware of the high likelihood of adverse health effects for consumers.
Biomet agreed to a settlement of $350,000 for the plaintiff. This is likely the first of many lawsuits to be filed against Zimmer Biomet's Comprehensive Reverse Shoulder device.
2010 – A Class II recall was issued for 45 of the implants sold in eight states – New York, Maryland, Virginia, Alabama, Texas, Oklahoma, Colorado, and South Dakota. A Class II recall is issued when a drug or device may cause "temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
Center for Devices and Radiological Health. "Medical Device Recalls - Zimmer Biomet Recalls Comprehensive Reverse Shoulder Due to a High Fracture Rate." U.S. Food and Drug Administration Home Page, Center for Devices and Radiological Health, www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm541862.htm.
"Class 2 Device Recall PROMOS Inclination Set." Accessdata.fda.gov, 14 Jan. 2010, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=89389
Sandberg, Josh. "Zimmer Biomet Recalls Comprehensive Reverse Shoulder Due to a High Fracture Rate." DePuy Synthes Launches The First 3D Simulation Assisted Orthopaedic External Circular Fixation Device, Feb. 2017, www.orthospinenews.com/2017/02/17/zimmer-biomet-recalls-comprehensive-reverse-shoulder-due-to-a-high-fracture-rate/.
Last Modified: November 7th, 2019 @ 03:42 pm
A shoulder replacement device is used to restore shoulder movement. Unfortunately, some devices have been found to fracture at a much higher rate. Since then, various shoulder replacement lawsuits have been filed across the country.
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