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Zimmer Biomet Shoulder ReplacementHigh Rate of Fracture Could Lead to Injury or Death

Zimmer Biomet Shoulder Lawsuit

The Zimmer Biomet Comprehensive Reverse Shoulder Replacement device is used to restore shoulder movement. Unfortunately, devices distributed to the market between 2008 and 2015 have been found to fracture at a much higher rate than Zimmer Biomet indicated on the device's label. A Class I Recall, the most serious recall possible, was issued to warn individuals of the dangers associated with the medical device. Since then, various Zimmer Biomet Shoulder lawsuits have been filed across the country.

Litigation Updates

Class I Recall Issued

February 2017 – A Class I recall was issued for the Zimmer Biomet Comprehensive Reverse Shoulder System. A Class I recall is the most serious recall issued by the FDA indicating a serious risk of serious injuries or even death.

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.

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."

What is a Reverse Shoulder Replacement?

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.

Reverse 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.

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.

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.

 

Injuries We’re Pursuing in a Zimmer Biomet Shoulder Lawsuit

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:

  • 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 reverse shoulder replacement device, please contact a knowledgeable attorney.

 

Zimmer Biomet Shoulder Lawsuit

If you think you have a potential case against Zimmer Biomet and their Comprehensive Reverse Shoulder Replacement device, we would be happy to talk. TorHoerman Law offers free, no-obligation case evaluations.

We have a dedicated team of Zimmer Biomet 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.

+ - References

"Shoulder Recall Lawsuit - Learn Instantly If You Qualify." TruLaw, trulaw.com/zimmer-biomet-reverse-shoulder-lawsuits/.

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.

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/.

 

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