The field of prosthetic surgery has expanded exponentially over the past decade. Medical and dental implants that were once pipe dreams are now reality and improving the quality of life for thousands of patients. Research is continuing in this area, offering promising futures for the injured, arthritic and disabled.
However, for every two steps forward, a discouraging reversal occurs. Such is the case with Zimmer Biomet’s Comprehensive Reverse Shoulder System.
At the end of 2016, the U.S. Food and Drug Administration (FDA) issued a Class I recall on all unused shoulder replacement devices associated with the system and sold between 2008 and 2015.
How the Biomet Shoulder Implant Works
Running from the shoulder to the elbow, the humerus is the long bone in each arm and is held in place at the shoulder by the rotator cuff tendons. When this connection is inflamed—a condition referred to as arthropathy or arthritis—it can lead to debilitating pain and some loss of arm use. Such a condition may require shoulder replacement.
Zimmer Biomet’s Comprehensive Reverse Shoulder is supposed to restore arm function and range of motion by replacing the damaged bone and joint between humerus and the shoulder bone. It is distinct from traditional shoulder replacement as ball and socket positions are reversed. Once in place, the device restores arm operation and kinetics to a significant degree.
How the Biomet Shoulder Device Malfunctions
While shoulder replacement devices carry—and must disclose—a small risk of fracture, the Zimmer Biomet components were fracturing with greater frequency than predicted by the manufacturer. This breakage requires subsequent revision surgery that carries the possibility of permanent shoulder immobility, bodily infection and even death.
Although litigation over the Biomet Comprehensive Reverse Shoulder Humeral is ongoing, surgeons and hospitals associated with implantation may also be legally vulnerable. Hence, the manufacturer is calling for a quarantine of all parts until they can be retrieved by company representatives. The FDA reports that the recall affects 3,662 devices sold to practices in the U.S., Canada, Australia, Chile, Colombia, South Korea and the Netherlands.
Class I Recall
The FDA is charged to protect the public from hazardous substances, devices and procedures. It does so through rigorous regimes of testing and research before allowing certain items on the market. However, when previously released items prove to be less than reliable, the FDA classifies corrective action on five different levels (in order from least to most serious):
- Safety Alert
- Market Withdrawal
- Class III Recall
- Class II Recall
- Class I Recall
Of the five, a Class I recall is the most serious, indicating that use of the device may cause consequential health problems or death. The Comprehensive Reverse Shoulder System is under a Class I recall.
What Does the Biomet Recall Mean?
Zimmer Biomet initiated recall procedures in December of 2016. First, the company sent out safety notices to its customers, asking each to return a certificate of acknowledgement. The customers were instructed to set apart any of the recalled devices in their inventories and await prompt retrieval by a Zimmer Biomet account executive.