DePuy Elbow Implant Recall Lawsuit | 2025 Latest Updates

If you or a loved one experienced loosening, dislocation, severe pain, or required revision surgery following a DePuy Synthes Radial Head Prosthesis System implant, you may be entitled to pursue compensation.

At Schmidt & Clark, LLP, we are dedicated to helping individuals who have suffered due to these defective elbow implants. Our experienced legal team is here to guide you through the process and fight for the compensation you deserve.

Contact Schmidt & Clark, LLP today for a free, no-obligation consultation.

DePuy Elbow Implant Recall Lawsuit Overview

Court filings assert that DePuy Synthes, a subsidiary of Johnson & Johnson, produced a faulty elbow implant and neglected to inform both the public and healthcare professionals about the possibility of loosening, malfunction of the medical device, and additional risks. The lawsuits primarily focus on the Radial Head Prosthesis System, which has been linked to more than 40 reported cases of device loosening.

In January 2017, Johnson & Johnson issued a global recall of the device after multiple patients experienced serious complications.

Latest DePuy Elbow Implant Recall Lawsuit Updates

As of 2025, lawsuits filed over complications alleged from DePuy Synthes elbow replacements are still in the early stages, and no major settlements have been reached to our knowledge.

However, the fact that DePuy pulled the Radial Head Prosthesis System off the market indicates the company is aware of the dangers associated with the device.

Here are the key developments in the DePuy elbow implant litigation:

• December 2016 – Johnson & Johnson announced a global recall of its DePuy Synthes Radial Head Prosthesis amid more than 40 reports of loosening in the component that anchors the implant in the arm’s radius bone [1].
• December 30, 2016 – J&J sent a letter to physicians stating that only the radial stem implanted into the radius had been associated with the loosening problem. The company indicated the cause appeared to be “multifactorial” but they were unable to fully characterize these factors [2].
• February 2013 – DePuy recalled 147 of the DePuy Synthes Radial Head Prosthesis Systems due to a problem with their trial head, which could come loose from the stem during surgery [3].

FDA Reports and Statistics

According to the National Institute of Health, between 2014 and the time of the recall in December 2016, the U.S. Food and Drug Administration (FDA) had received more than 40 reports of this device loosening. The recall involved 50,311 units of the DePuy Synthes Radial Head Prosthesis System [4].

The system was approved in June 2011 through the FDA 510(k) process, which allows a company to market certain devices if they can simply show that the product is “substantially equivalent” in safety and effectiveness to other devices already on the market. They do not have to put the device through more rigorous safety tests.

A study assessed 77 surgical meshes cleared by the FDA between 2013 and 2015, finding that they were based on 771 interconnected predicate claims from 400 other devices.

Of concern, 16% of the recently cleared devices were connected through equivalence claims to three predicate meshes that had been recalled due to design and material-related flaws.

DePuy Elbow Implant Injuries & Side Effects

Patients who received the DePuy Synthes Radial Head Prosthesis System have reported numerous serious complications and side effects that can significantly impact their quality of life.

• Implant Loosening: The most common complication, occurring when the stem loosens from the radius bone.
• Severe Pain: Particularly in the forearm area, which may be the first sign of implant failure.
• Osteolysis (Bone Loss): Progressive destruction of bone tissue around the implant.
• Bone Fractures: Weakening of surrounding bone can lead to fractures.
• Soft Tissue Damage/Irritation: Inflammation and damage to surrounding tissues.
• Premature Failure: Device failing earlier than its expected lifespan.
• Need for Revision Surgery: Additional surgeries to remove and replace the defective implant.

Do You Qualify for a DePuy Elbow Implant Recall Lawsuit?

You may qualify for a DePuy Elbow Implant Recall lawsuit if:

• You received a DePuy Synthes Radial Head Prosthesis System implant
• You experienced serious complications such as implant loosening, severe pain, bone loss, or other side effects
• Your complications required medical treatment or additional revision surgery
• You can provide medical documentation linking your injuries to the DePuy elbow implant

Evidence Required for a DePuy Elbow Implant Recall Lawsuit

To successfully pursue a DePuy elbow implant lawsuit, you will need to provide certain evidence, including:

• Medical records documenting your original elbow replacement surgery
• Documentation of complications and subsequent medical treatments
• Records of any revision surgeries performed
• Proof that a DePuy Synthes Radial Head Prosthesis System was implanted

Damages You Can Recover

By filing a lawsuit against the maker of the DePuy Elbow, you may be entitled to collect compensation for:

• All current and future medical expenses related to the treatment of your injury
• Lost wages due to inability to work
• Pain and suffering
• Other damages related to your complications

DePuy Elbow Implant Recall Information

In January 2017, Johnson & Johnson announced that it was recalling its DePuy Synthes radial head prosthesis amid more than 40 reports of loosening in the component that anchors the implant in the arm’s radius bone.

Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors – the company said

Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market

Additionally, in February 2013, DePuy recalled 147 of the DePuy Synthes Radial Head Prosthesis Systems due to a problem with their trial head, which could come loose from the stem during surgery.

Other DePuy Cases We’ve Taken:

• DePuy Pinnacle Hip Replacement Lawsuit
• DePuy Craniomaxillofacial Distraction System Lawsuit
• Depuy ASR™ Hip Replacement Problems

Statute of Limitations for DePuy Elbow Implant Recall Lawsuits

The statute of limitations for filing a DePuy elbow implant lawsuit varies by state, typically ranging from 1-3 years from the date you discovered or should have discovered your injury. It’s crucial to consult with an attorney as soon as possible to ensure your legal rights are protected.

FAQs

1. What is the DePuy Synthes elbow lawsuit about?

The DePuy Synthes elbow lawsuit involves claims that the elbow implant devices are defective, causing complications such as loosening, fractures, and the need for revision surgery. Plaintiffs allege failure to warn and product liability.

2. Who can file a DePuy Synthes elbow lawsuit?

Individuals who have received a DePuy Synthes elbow implant and experienced complications such as pain, implant failure, or required additional surgeries may be eligible to file a lawsuit.

3. What types of compensation are available in a DePuy Synthes elbow lawsuit?

Compensation available in a DePuy Synthes elbow lawsuit may include medical expenses, lost wages, pain and suffering, and costs associated with additional surgeries. The exact compensation depends on the specifics of each case.

4. What is the Radial Head Prosthesis System?

The Radial Head Prosthesis System features 2 pieces used as a primary or revision joint of the radial head of the elbow. It consists of a cobalt chrome head and titanium alloy stem components with integral side-loading and screw application for in-situ assembly.

5. How do I know if my DePuy elbow implant is failing?

Signs of a failing DePuy elbow implant include pain in the forearm, swelling, and limited range of motion. Diagnostic tests such as X-rays, bone scans, or other imaging may be needed to confirm implant failure.

6. Has there been a settlement for DePuy elbow implant lawsuits?

As of 2025, no major settlements have been announced for DePuy elbow implant lawsuits. Cases are still in the early stages of litigation.

7. How long do I have to file a DePuy elbow implant lawsuit?

The time limit to file varies by state but typically ranges from 1-3 years from when you discovered or should have discovered your injury. Consult with an attorney promptly to protect your rights.

8. What evidence do I need for a DePuy elbow implant lawsuit?

You’ll need medical records of your original surgery, documentation of complications, records of any revision surgeries, and proof that a DePuy Synthes Radial Head Prosthesis System was implanted.

9. Why was the DePuy Synthes Radial Head Prosthesis System recalled?

The system was recalled in January 2017 after more than 40 reports of loosening in the component that anchors the implant in the arm’s radius bone. The company stated they could not fully characterize the factors causing the loosening.

10. What other DePuy products have had issues?

Other DePuy products with reported issues include the DePuy Pinnacle Hip Replacement, DePuy Craniomaxillofacial Distraction System, and Depuy ASR™ Hip Replacement.

Related: All the Medical Devices Lawsuits that We’ve Covered

Get a Free DePuy Elbow Implant Recall Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for complications related to DePuy elbow implants. Most states have statutes of limitations that restrict the amount of time you have to file a claim after discovering your injury.

The Medical Device Litigation Group at Schmidt & Clark, LLP offers:

• Free, confidential consultations.
• No upfront costs or fees.
• Payment only if we win your case.
• Nationwide representation, accepting new cases in all 50 states.

References

1. https://www.drugwatch.com/depuy-elbow-replacement/lawsuits/
2. https://attorneygroup.com/lawsuits/defective-medical-devices/depuy-elbow-implant-lawsuit/
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117017
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471