Shoulder Replacement LawsuitHigh Rate of Fracture Could Lead to Injury or Death

Shoulder Replacement Lawsuit

If you or a loved one underwent shoulder replacement surgery calling for a Zimmer Biomet shoulder replacement device and subsequently suffered injuries related to the device, you may be entitled to compensation through a Zimmer Biomet Shoulder Replacement lawsuit. The Zimmer Biomet Shoulder Replacement device recall cites numerous documented injuries associated with the product. Individuals who suffered these injuries should contact a Zimmer Biomet Shoulder Replacement lawyer immediately. You may be eligible to participate in the Zimmer Biomet lawsuit.

Contact TorHoerman Law for a free, no-obligation case consultation with a product liability lawyer today or use our chatbot below for an instant online case evaluation now.

 

 

What is a Zimmer Biomet Shoulder Replacement Device?

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.

 

 

Zimmer Biomet Comprehensive Reverse Shoulder Replacement

Zimmer Biomet Comprehensive Reverse Shoulder Replacement devices were introduced to the market in 2008 by Zimmer Biomet, a medical technology manufacturer based in Indiana. The product was used to treat a range of injuries related to shoulder injuries.

 

Zimmer Biomet Shoulder Replacement Recall

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.

 

 

Smith and Nephew Shoulder System Recall

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.

 

 

Shoulder Replacement Lawsuit Qualifying Injuries

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 Shoulder replacement injuries:

  • Shoulder replacements that have fractured;
  • Shoulder replacements that have failed;
  • Or shoulder replacements where a revision was required.

If you have had complications as a result of a shoulder replacement device, please contact a TorHoerman Law to discuss your options. You may qualify for a Zimmer Biomet Shoulder Replacement lawsuit.

 

 

Do I Qualify for a Zimmer Biomet Shoulder Replacement Lawsuit?

If you or a loved one received a Zimmer Biomet device or Smith & Nephew device that fractured, failed, or had another issue resulting in a revision, you may qualify for a shoulder replacement lawsuit. Contact a Zimmer Biomet Shoulder Replacement lawyer from TorHoerman Law for a free, no-obligation consultation to find out whether you qualify.

 

 

Filing Zimmer Biomet Shoulder Replacement Lawsuit

If you believe that you qualify for the Zimmer  Biomet Shoulder Replacement lawsuit, the first step is to mitigate your injuries and other damages by seeking proper medical attention right away and following your doctor’s orders. Mitigation greatly increases your chances of a successful shoulder replacement lawsuit.

Next, you should familiarize yourself with the civil litigation process so that you are aware of what to expect of your Zimmer  Biomet Shoulder Replacement lawsuit.

You should then begin to gather evidence to help build your claim. This can include medical records, personal testimony, photos of your injury, dates and calendars to create a timeline of your injury, bills associated with your injury, etc.

Finally, contact a Shoulder Replacement injury lawyer to act as your legal representative.

 

 

Hiring a Zimmer Biomet Shoulder Replacement Injury Lawyer

Hiring a personal injury lawyer to act as your legal representative is one of the most important steps in your lawsuit. Be sure to find a lawyer who is experienced, dedicated to your case, and has the resources and skill to litigate to the fullest extent.

Your attorney will help you in the process of gathering evidence, which they will use to prove that liability falls on the manufacturer. They will also assess your damages to determine the total amount of losses that you incurred because of your injury.

Your Zimmer Biomet Shoulder Replacement injury lawyer will then work to gain you compensation for those damages through the court system.

 

 

TorHoerman Law, Shoulder Replacement Injury Lawyers

If you believe that  you have a shoulder replacement lawsuit case against Zimmer Biomet or Smith & Nephew, contact TorHoerman Law today.

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.

TorHoerman Law offers free, no-obligation case consultations. You can also use our chatbot to get an instant online case evaluation and learn if you qualify for the Zimmer Biomet Shoulder Replacement lawsuit right now!

Worried about legal fees?

The consultation and evaluation are free. Also, TorHoerman Law operates on a contingency fee basis, so you do not ever have a bill until we get you compensated for your injuries. No compensation? No fees. That is our guarantee to work as hard as possible to get your the financial compensation that you deserve for your injuries.

 

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Zimmer Biomet Shoulder Replacement Lawsuit | Zimmer Biomet Recall
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Zimmer Biomet Shoulder Replacement Lawsuit | Zimmer Biomet Recall
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Zimmer Biomet Shoulder Replacement Lawsuit | get an instant online case evaluation now for free from a Zimmer Biomet Shoulder Replacement Injury Lawyer!
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Litigation Updates

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.

 

Manufacturer Issued Urgent Medical Device Recall Notice

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.

 

First Zimmer Shoulder Replacement Case Settled

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.

 

Class II Recall Issued

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."

References

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: October 6th, 2020 @ 03:12 pm

Is the Zimmer Biomet Shoulder Replacement device recalled?

Zimmer Biomet Comprehensive Reverse Shoulder Replacement devices were introduced to the market in 2008. 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 corrective surgery that could increase the likelihood of serious health consequences such a permanent loss of shoulder function, infection, or death. A Zimmer Biomet shoulder replacement lawsuit has been filed on behalf of individuals who received the device and suffered injuries related to the Biomet.