Attorney Jessie Paluch, founder of TruLaw, has over 25 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.
Zimmer Biomet Shoulder Implants were able to obtain approval of its Comprehensive Reverse Shoulder device without any human testing, but the device was pulled from the market in 2010 after complaints of fracturing.
The U.S. Food and Drug Administration (FDA) approved the Zimmer Shoulder Replacement device through its controversial 510(k) protocol rather than the lengthy and more thorough standard premarket approval process.
The 510(k) process allows a device to be approved on a “fast-track” basis if it can be shown to be substantially similar to a previously approved product already on the market.
In 2008, Zimmer told the FDA that the Comprehensive Reverse Shoulder was substantially equivalent to five different systems on the market at the time, one made by Biomet and the others by Zimmer (they were separate companies until Zimmer purchased Biomet in 2014 for $13.4 billion).
In 2010, the FDA issued a Class II recall of the Biomet shoulder replacement, meaning that the device could cause temporary or reversible complications.
Six years later after multiple incidents of fracturing, the recall was upgraded to a Class I, the most serious type of recall the FDA issues.
According to the FDA, Zimmer Biomet Reverse Shoulder Injuries such as these fractures could result in revision surgeries that could lead to serious health consequences including permanent loss of shoulder function, infection, and even death.
Death related to shoulder implants replacement fractures typically is associated with pulmonary, cardiac, and abdominal complications, according to a study published in the Journal of Shoulder and Elbow Surgery.
Researchers conducting this study found that patients who suffered a fracture after shoulder replacement surgery had a six times higher incidence of death within 30 days than the general population, and concluded that despite advances in technique and implant design, instability after reverse total shoulder replacement surgery remains a distinct possibility for many patients.
Experienced Attorney & Legal SaaS CEO
With over 25 years of legal experience, Jessie 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 reliable legal information with her readers!
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
At TruLaw, we fiercely combat corporations that endanger individuals’ well-being. If you’ve suffered injuries and believe these well-funded entities should be held accountable, we’re here for you.
With TruLaw, you gain access to successful and seasoned lawyers who maximize your chances of success. Our lawyers invest in you—they do not receive a dime until your lawsuit reaches a successful resolution!
Do you believe you’re entitled to compensation?
Use our Instant Case Evaluator to find out in as little as 60 seconds!
Camp Lejeune’s water contamination issue spanned several decades starting in the 1950s. Exposure to these chemicals has been linked to various serious health issues, including cancer, organ diseases, and death.
Research is increasingly suggesting a link between the use of Tylenol during pregnancy and the development of neurodevelopmental disorders, such as autism and ADHD, in infants.
Legal action is being taken against manufacturers of Aqueous Film-Forming Foam (AFFF), a chemical used in fighting fires. The plaintiffs allege that exposure to the foam caused health issues such as cancer, organ damage, and birth and fertility issues.
Here, at TruLaw, we’re committed to helping victims get the justice they deserve.
Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.
Would you like our help?
Austin, Kentucky-based Kenny’s Farmhouse Cheese has recalled batch 231129 of its St. Jerome cheese after routine testing conducted by the Kentucky Department of Public Health showed the organism Listeria monocytogenes to be present in a single package, reports the FDA. While healthy people infected with
East Windsor, New Jersey-based Aurobindo Pharma USA, Inc. has recalled a single lot of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets on behalf of AuroHealth because the product does not have a manufacturer label, reports the FDA. The voluntary,
Indio, California-based Stutz Packing Company has recalled its 1-pound bags of shelled walnuts because a potential Listeria monocytogenes contamination has been identified in the product, reports the FDA. While healthy people infected with the organism may only experience short-lived symptoms like “high fever, severe headache,