North American Elbow Replacement Market Expected to Grow, Despite Recent DePuy Synthes Implant Recall

Published on April 17, 2017 by Sandy Liebhard

The North American market for elbow replacement is expected to grow by at least 3.6% annually, according to the research and consulting firm GlobalData. Most of the growth is expected to come from the U.S., where, ironically, federal regulators only recently announced a Class II recall for the DePuy Synthes Radial Head Prosthesis System.

The North American market  (U.S., Canada, and Mexico)  was worth about $23 million in 2016. GlobalData expects that it will reach roughly $29.5 million by 2029. The U.S. market is expected to grow by 3.7% during the same period,  from $18.6 million in 2016 to $24.0 million in 2023.

The report notes that elbow replacement is still a relatively small market dominated by just a handful of medical device makers, including Wright Medical, Stryker, Zimmer Biomet, and Integra LifeSciences.

“Results from long-term clinical research trials on existing prostheses will determine which companies gain or lose market share, and as more data emerges on existing solutions, it is likely that a winner-takes-all scenario will occur, in which the best-performing implant will possess a disproportionately larger portion of the market,” Tobe Madu, MSc, Healthcare Analyst for GlobalData, said in a statement announcing the group’s findings.

DePuy Synthes Elbow Implant Recall

The GlobalData report does not mention DePuy Synthes or its recent recall for the Radial Health Prosthesis System, an implant used in primary and revision joint replacement of the radial head. DePuy Synthes removed the Radial Head Prosthesis System from the global market in December 2016 due to post-operative loosening of the radial stem at the bone-stem interface. Elbow replacement patients who experience radial stem loosening could suffer other debilitating side effects, including:

• Osteolysis
• Poor joint mechanics
• Pain
• Post-operative fracture
• Soft tissue damage

Though the loosening issue only affected the radial stem component, the entire Radial Head Prosthesis System was included in the market withdrawal.

“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,” DePuy Synthes 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.”

In February, the FDA designated the DePuy elbow implant recall a Class II recall, which indicates recalled components may cause temporary or medically reversible health consequences.