Skeletal Dynamics Lawsuit Claims Defective Prosthetic Elbow Implant Resulted in Chronic Pain, Medical Monitoring

Lawsuit indicates manufacturer should have known about problems with the Skeletal Dynamics Align Radial Head System, which allegedly makes the implant prone to fail.

A North Carolina man’s lawsuit alleges that a defective version of the Skeletal Dynamics Align Radial Head System was implanted in his arm, which resulted in a loss of elbow function and the potential need for additional surgeries.

The complaint (PDF) was brought by Daniel A. Victor in the U.S. District Court for the Middle District of North Carolina on November 20, naming Skeletal Dynamics Inc. as the defendant.

The Skeletal Dynamics Align Radial Head System is an implant used in elbow reconstruction to replace a damaged radial head, which allows the elbow to bend, straighten and rotate the forearm. 

The device features a one-piece implant with an anatomical alignment guide and a stem that seats into the joint. It is generally used for patients who have pain or reduced elbow function due to injury or degenerative conditions.

However, according to Victor’s lawsuit, the Align Radial Head System has also been the subject of at least nine reported failures between July 2022 and September 2024. Those incidents allegedly involved set-screw back-out, metallic debris and metallosis, which are the same problems Victor says he experienced when his implant failed.

According to the lawsuit, Victor received an Align Radial Head System in 2018, after injuring his right arm. He began experiencing pain, clicking, instability and reduced elbow function last year, prompting revision surgery in August 2025.

During that procedure, surgeons discovered multiple signs of implant failure, including:

• A loosened set screw with exposed threads
• Metallic debris dispersed throughout the joint
• Metallosis, marked by inflammation and tissue damage from metal particles
• An inflammatory soft-tissue reaction

The complaint indicates that the surgeon found no evidence of improper placement or surgical error, suggesting the implant failed due to underlying design or manufacturing defects.

Victor also claims Skeletal Dynamics introduced a redesign of the radial head implant sometime between 2010 and 2023, demonstrating that safer alternatives existed. Despite this, he claims the company continued distributing both the original and updated versions while reports of similar failures accumulated in federal MAUDE data. MAUDE stands for the U.S. Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience database

The lawsuit argues that these repeated incidents show Victor’s injuries were foreseeable, rather than an isolated event. Victor indicates that he continues to suffer from permanent loss of function, chronic pain and biomechanical instability, which requires medical monitoring and may result in additional surgeries.

“The repetition of identical failures across years of MAUDE reports demonstrates that Plaintiff’s injury was not an isolated or unpredictable event, but a foreseeable consequence of a known design hazard that Defendant had notice of prior to Plaintiff’s implantation and prior to Plaintiff’s failure.”

— Daniel A. Victor v. Skeletal Dynamics Inc.

Victor raises allegations of strict liability — design defect, strict liability — manufacturing defect, negligence, and breach of implied warranty of merchantability. He is seeking compensatory and punitive damages.

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