Last year, Biomet paid $350,000 to settle a lawsuit from a person who was implanted with two Comprehensive Reverse Shoulders in 2009 and 2010. Both of the implants were recalled and eventually failed — Case No. 14-02667.
In December 2016, Zimmer Biomet sent an “Urgent Recall Notice” to warn surgeons that some Comprehensive Reverse Shoulder Systems are fracturing at a higher rate than expected.
The FDA designated it a Class I recall in February 2017 and issued the following warning:
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
Implants made after September 2011 have “design enhancements that increase the strength of the device,” according to a statement from Zimmer Biomet. The recall involves the following product:
- Product Name: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
- Number of Recalled Products: 3,662
- Distribution Dates: October, 2008 to September, 2015
- Manufacturing Dates: August 25, 2008 to September 27, 2011
- Product Codes: KWS, PAO
- Lot Number: All Lots With Part #115340
- Click here to see a list of recalled lots
Biomet also issued two previous Class II recalls for the Comprehensive Reverse Shoulder — one recall in September 2010 due to fractures between the baseplate and trunnion, and another recall in April 2011 due to an assembly error.
Reverse shoulder surgery is relatively new, with the first implants approved in 2004. The surgery switches the “ball-and-socket” in the shoulder — replacing the shoulder socket with a metal ball, and cutting off the top of the arm bone and attaching a plastic cup. This is useful for people with torn rotator cuffs and severe shoulder arthritis.
There are also unique problems with reverse shoulder surgery. Loosening, instability, and fracture of the “humeral tray” or baseplate is an ongoing issue that manufacturers have tried to fix with locking screws. Studies also show high rates of infection, nerve damage, and hematoma (blood or fluid in the joint).