Zimmer Biomet Reverse Shoulder Lawsuits

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Jessica Paluch-Hoerman

Attorney Jessica Paluch-Hoerman, founder of TruLaw, has over 28 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.

Overview of the Zimmer Biomet Reverse Shoulder Lawsuits

Device Recall – Biomet comprehensive reverse shoulder replacement systems have been recalled.

Shoulder Recall Lawsuits are moving forward.

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery; Zimmer Biomet Comprehensive Reverse Shoulder System; FDA RECALL – Zimmer Biomet Reverse Shoulder Injuries Lead To Recall Due To A High Fracture Rate; High Fracture Rate Of Zimmer Biomet Shoulder System Could Lead To Death; Zimmer Biomet Shoulder Replacement Timeline; Zimmer Biomet Reverse Shoulder Lawsuits

Zimmer Biomet Reverse Shoulder Injuries Lead to Recall

On December 20, 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers.

This Notice was directed mostly toward healthcare providers in an effort to account for each of the 3,662 devices distributed between October 2008 and September 2015.

But, it is important that consumers take note of this dangerous recall.

Any individual who received a total shoulder replacement between October 2008 and December 2016, should contact their healthcare provider immediately to determine if the Recalled Zimmer Biomet Comprehensive Reverse Total Shoulder Replacement Device was utilized.

Table of Contents

What is a Reverse Shoulder Replacement Surgery?

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery

In shoulder replacement surgery, doctors replace the ends of the damaged upper arm bone (humerus) and usually the shoulder bone (scapula) or cap them with artificial surfaces lined with plastic or metal and plastic.

Reverse shoulder replacement surgery is a newer procedure used on people who have painful arthritis in their shoulder and also have damage to the muscles around the shoulder.

shoulder replacement

In a reverse shoulder replacement surgery, the surgeon removes the damaged bone and smooths the ends, he or she attaches the rounded joint piece to the shoulder bone and uses the cup-shaped piece to replace the top of the upper arm bone.

Zimmer Biomet Comprehensive Reverse Shoulder System

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery; Zimmer Biomet Comprehensive Reverse Shoulder System

An estimated 90 percent of all shoulder replacements should last 10 years or more, so the FDA pays attention when implanted devices fail within just a few years of implantation, such as in the case of the Zimmer Biomet Comprehensive Reverse Shoulder System.

The Zimmer Biomet Shoulder Replacement was designed to restore arm movement to patients undergoing reverse shoulder replacement.

FDA approval process

Zimmer Biomet received clearance for the Biomet Shoulder Replacement in 2008 through the controversial 510(K) program, an expedited clearance process that allows medical devices to go to market without the normal safety testing when the device maker can show that the new device is substantially similar to an already approved device.

FDA RECALL – Zimmer Biomet Reverse Shoulder Injuries lead to Recall due to a High Fracture Rate

On February 16, 2017, the FDA issued a Class 1 recall of the Zimmer Biomet Comprehensive Reverse Shoulder System.

The Class 1 recall is the most serious type of recall, reserved for devices that may cause serious injuries or death.

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery; Zimmer Biomet Comprehensive Reverse Shoulder System; FDA RECALL – Zimmer Biomet Reverse Shoulder Injuries Lead To Recall Due To A High Fracture Rate

According to the FDA, the Zimmer Biomet Comprehensive Reverse Shoulder replacement devices fractures at higher rates than is stated on the label.

Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or death.

High Fracture Rate of Zimmer Biomet Shoulder System Could Lead to Death

According to a May 2016 study of the Danish Shoulder Arthroplasty Registry between 2006 and 2012, fracture patients had a 6 times higher incidence of death within 30 days than the general population.

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery; Zimmer Biomet Comprehensive Reverse Shoulder System; FDA RECALL – Zimmer Biomet Reverse Shoulder Injuries Lead To Recall Due To A High Fracture Rate; High Fracture Rate Of Zimmer Biomet Shoulder System Could Lead To Death

According to this study, pulmonary, cardiac, and abdominal causes of death were common.

Zimmer Biomet Shoulder Replacement Timeline

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery; Zimmer Biomet Comprehensive Reverse Shoulder System; FDA RECALL – Zimmer Biomet Reverse Shoulder Injuries Lead To Recall Due To A High Fracture Rate; High Fracture Rate Of Zimmer Biomet Shoulder System Could Lead To Death; Zimmer Biomet Shoulder Replacement Timeline

2008:

  • Zimmer Biomet received clearance for the Biomet Shoulder Replacement through the controversial 510(K) program.

2010:

  • FDA Class II Recall of Zimmer Biomet Comprehensive Shoulder Humeral Tray with Locking Ring after receiving complaints regarding the fracturing of the device.

2016:

  • Biomet settles with a Colorado man who filed a lawsuit for damages related to failure of his Comprehensive Reverse Shoulder Replacement.

December 20th, 2016:

  • Urgent Medical Device Recall Notice sent by Zimmer to all affected customers.

February 16th, 2017:

  • FDA Class I Recall of Zimmer Biomet Comprehensive Reverse Shoulder System.

Zimmer Biomet Reverse Shoulder Lawsuits

Product liability lawsuits are currently being filed against Zimmer-Biomet alleging that the Comprehensive Reverse Shoulder Systems failed.

As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices.

Zimmer Biomet Faulty Reverse Shoulder Implant Device; What Is A Reverse Shoulder Replacement Surgery; Zimmer Biomet Comprehensive Reverse Shoulder System; FDA RECALL – Zimmer Biomet Reverse Shoulder Injuries Lead To Recall Due To A High Fracture Rate; High Fracture Rate Of Zimmer Biomet Shoulder System Could Lead To Death; Zimmer Biomet Shoulder Replacement Timeline; Zimmer Biomet Reverse Shoulder Lawsuits

In addition to revision surgeries, shoulder implant lawsuits allege that patients have been put at an increased risk for:

  • Bone Loss
  • Device Fracture
  • Device Failure
  • Permanent loss of shoulder function
  • Infection
  • Death

Zimmer Biomet Reverse Shoulder Lawsuits Frequently Asked Questions

Published By:
Picture of Jessica Paluch-Hoerman
Jessica Paluch-Hoerman

Managing Attorney & Owner

With over 25 years of legal experience, Jessica Paluch-Hoerman is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share the most reliable, accurate, and up-to-date legal information with our readers!

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