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Zimmer Biomet Shoulder Replacement Lawsuit 2024 Update

Zimmer Biomet has issued a Class I Recall [1] for its Comprehensive Reverse Shoulder Device because the implants may fracture after surgery, which may cause permanent loss of shoulder function, infection or even death.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

Free Confidential Zimmer Biomet Comprehensive Reverse Shoulder Replacement Lawsuit Evaluation: If you or a loved one suffered complications after Zimmer Biomet Comprehensive Reverse shoulder surgery, you should contact our law firm immediately for a free case evaluation. You may be entitled to compensation by filing a Zimmer Biomet Lawsuit and our dangerous drug lawyers can help.

Zimmer Biomet Recalls Medical Device Over Decreased Shoulder Function, High Fracture Rate

Zimmer Biomet initiated the recall after receiving a higher-than-expected number of reports of its Zimmer Biomet Comprehensive Reverse Shoulder System fracturing, which could require revision surgery leading to adverse health complications including permanent loss of shoulder motion, infection, or rarely, death.

The Zimmer Reverse Shoulder is a shoulder replacement device designed to help restore movement in patients with shoulder tears who have severe arthritis and previously failed shoulder joint replacement.

This is a Class I Food and Drug Administration Recall, which is reserved for Zimmer Biomet Comprehensive Reverse shoulder devices that 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 FDA released the following information regarding the product. This is pertinent information for any patient who thinks they might have a defective Zimmer Biomet Comprehensive Reverse implant.

Zimmer Biomet Shoulder Replacement Class 1 Recall Information

  • Product Description: Comprehensive Reverse Shoulder Replacement Device Humeral Tray Model 115340
  • Trade Name: Zimmer Biomet Shoulder Replacement Device
  • Product Code: KWS, PAO
  • Lot Numbers: All lots with part number 115340
  • Distribution Dates: October 2008 to September 2015
  • Manufacturing Dates: Aug 25, 2008 to Sep 27, 2011
  • Shoulder Replacement Devices Recalled: 3662

Zimmer Biomet Shoulder

What is the Zimmer Reverse Shoulder Replacement Surgery Device?

In shoulder blade surgery, a medical device is surgically implanted into the shoulder to repair complex fractures and restore range of motion in a patient who suffers from rotator cuff deficiencies, and/or alleviate pain.

The goal of the surgery is to improve arm movement. Although less common than total shoulder replacement, reverse shoulder implant devices are used in thousands of surgeries a year across the U.S.

According to a 2023 research by the National Center for Biotechnology and Information, data from 5 registries and 15 studies were included. Rates of implant breakage after shoulder arthroplasty were reported at 0.06–0.86% in registries versus 0.01–6.65% in clinical studies. [1]

The breakage rate per 100,000 observed component years was 10 in clinical studies and 9 in registries. There was a revision rate of 0.09% for registry data and 0.1% for clinical studies within 10 years. The most frequently affected component in connection with implant fracture was the glenoid insert.

Clinical studies revealed a similar incidence of implant failure compared to data of worldwide arthroplasty registries. These complications arise mainly due to breakage of screws and glenospheres and there seems to be a direct correlation to loosening – National Center for Biotechnology and Information.

Shoulder revision surgeries are typically performed on patients who have either already undergone a previous shoulder surgery that failed or have large rotator cuffs that caused them to develop arthropathy.

In some cases, patients may not be aware of the specific brand of device used in surgery. If you received a reverse shoulder implant between 2008 and 2015, you should contact your doctor and/or surgeon for additional information about the device used. The device you received may qualify for a shoulder replacement lawsuit.

Shoulder Replacement Lawsuit

What’s the Problem with the Comprehensive Reverse Shoulder Humeral Tray?

Patients who have undergone shoulder surgery using the Zimmer Biomet Shoulder Humeral Tray are more likely than patients with other implants to require revision surgery. Every surgery in itself poses risks to the patient, who must undergo general anesthesia and work through rehab to recover.

Having a second surgery increases risks such as infection, permanent loss of shoulder motion, or something going wrong with the device implantation, among many other factors.

The problem with manufacturer Zimmer Biomet Shoulder is that negligence in design and testing before the product was released and implanted into thousands of patients has caused life-threatening and sometimes life-ending problems.

While the company marketed the device as a way to help patients regain a natural arm motion, it has had the opposite effect in many cases.

The FDA approved the Comprehensive Reverse Shoulder Humeral Tray in 2008 through the 510(k) Pre-Market Approval process, which enables products that are substantially similar to products that are already on the market to be released, without a requirement of human clinical trials.

According to the Medical Device and Diagnostic Industry, the 2016 recall isn’t the first issue Zimmer Biomet Shoulder has experienced. In September 2010, the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring (49mm standard) was recalled by Biomet because of complaints that the device was fracturing at the joint. [2]

In 2011, the Custom Comprehensive Reverse Shoulder Humeral Trays (bio-modular base 44mm standard) were recalled because some of the trays may contain a locking ring that was not assembled correctly.

The FDA designated both these recalls as Class II, which indicates that the devices may cause temporary or medically reversible negative health issues.

Who Are Comprehensive Reverse Shoulder Humeral Tray Patients?

Patients who have received the Zimmer Biomet Comprehensive Reverse Shoulder Humeral Tray are typically those who have lost control of their natural arm movement.

Many times, these patients have suffered a rotator cuff tear which is a severe type of shoulder arthritis in different muscles, called cuff tear arthropathy.

When patients do not respond to traditional shoulder replacement surgery, reverse shoulder replacement surgery may be recommended.

When considering the differences between traditional shoulder replacement surgery and reverse shoulder replacement surgery, in regular shoulder replacement, the implant replicates the normal anatomy of the shoulder. As the name implies, in reverse surgery, the design is reversed to be opposite the normal anatomy.

This allows patients with cuff tear arthropathy to use the deltoid muscle to move the arm beside the rotator cuff.

Dangerous Drug

Which Injuries Qualify for a Lawsuit and Statistics

The fracturing of a shoulder replacement device causes the implant 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.

The law offices of Schmidt & Clark, LLP, are currently accepting potential lawsuits on behalf of patients who suffered the following shoulder replacement injuries:

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

Overall, 7.26% of all revision surgeries were due to IB (0.67% of all primary SA).

The lowest number of fracture rates of encountered fractures out of all primary SA was found in the Emilia-Romagna Region and RIAP registry in Italy (0.06% in both registries), whereas the highest rates were seen in Norway (0.40%) and Australia (0.88%).

Experimental studies, case reports, and biomechanical studies were excluded because of heterogeneity of examined specimens or population. Registry data and those from clinical studies consider different populations due to different admission criteria. As a result, there is heterogeneity in the included population, which could be the reason for different results – NCBI said.

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

FDA Recommendation

If you underwent shoulder replacement surgery (regardless of whether you received a Zimmer Biomet Comprehensive Reverse Shoulder), you should contact your doctor if you feel anything out of the ordinary.

Medical Records

If you or a loved one has been injured by a defective shoulder implant, you may be entitled to compensation through the filing of a lawsuit and our law firm can help.

What is the Life Expectancy of a Zimmer Biomet Shoulder Replacement?

The failure rate for Zimmer Biomet shoulder replacements is about 1% per year. This means that 10% will fail within 10 years, 20% within 20 years, and so on.

Reverse Shoulder Replacement Surgery

The failure rate of a Zimmer Biomet shoulder replacement and anatomic shoulder replacement are very similar.

This is good news for Zimmer Biomet patients, because when the comprehensive reverse shoulder system was first introduced there was concern that they may not last long term, but research has shown that the Zimmer Biomet functions nearly as well as a standard replacement.

In most cases, Zimmer Biomet shoulder replacements fail by simply “wearing out”. The plastic liner on the socket cracks or comes loose over time. Joint replacements are constructed of metal and plastic, mechanical devices that wear out over time just like car parts do.

If you want to prolong the lifespan of your shoulder replacement, you should go easy on it. Most shoulder replacements are not meant for heavy-duty, repetitive lifting. Shoulder replacement patients should not lift more than 40 lbs with the operated arm regularly.

You should also be sure to choose a surgeon that has experience. Studies have shown that better outcomes are obtained by surgeons with a high level of experience in shoulder arthroplasty.

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Have you or a loved one suffered severe pain or injury from a defective medical device?

Get a Free Biomet Shoulder Replacement Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zimmer Biomet shoulder replacement lawsuits. Our law firm is handling individual litigation nationwide and is currently accepting new injury cases in all 50 states.

Free Zimmer Biomet Evaluation: Again, if you have problems with a Zimmer Biomet device, you should contact our law firm immediately. You may be entitled to a settlement by filing a Zimmer Shoulder Replacement Lawsuit and we can help.

References:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10565962/
  2. https://www.mddionline.com/orthopedic/high-failure-rate-forces-zimmer-biomet-to-recall-shoulders

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