The Biomet reverse shoulder recall was announced recently and affects many Americans because of high fracture rates.

In February 2017, the U.S. Food and Drug Administration announced a Biomet reverse shoulder recall. The FDA recalled the Comprehensive Reverse Shoulder replacement implant because of reports of higher-than-stated fracture rate.

Critics complain that the label for the medical device does not accurately state the high fracture rate. Fractures can result in serious complications. These complications include permanent loss of shoulder function, infection and possibly death.

This Biomet reverse shoulder recall affects devices made between August 25, 2008 and September 27, 2011 and that were distributed between October 2008 and September 2015. Over 3500 Biomet reverse shoulder implant devices have been affected by the Biomet reverse shoulder recall.

This Biomet reverse shoulder recall is classified as a Class I recall by the FDA. A class I recall is the most serious type of recall and is reserved for life-threatening devices.

What is a Reverse Shoulder Replacement?

A conventional shoulder replacement is similar to the regular anatomy of the shoulder. A plastic cup is attached to the shoulder socket and a metal ball is fitted into the upper arm, mimicking shoulder anatomy.

However, sometimes a patient’s rotator cuff is torn. In this case, the patient’s shoulder is not strong enough for a conventional shoulder implant. In this case, a reverse shoulder replacement may need to occur.

In a reverse shoulder replacement, the patient relies on different muscles to move the arm. Instead of the rotator cuff, a reverse shoulder replacement relies on the deltoid muscles to move the arm.

The reverse shoulder surgery was first developed in Europe in the 1980s and was approved by the FDA in 2003 for use in the United States.

Some patients are better candidates for this type of surgery than others. Candidates for reverse shoulder surgery include those who have a completely torn rotator cuff that cannot be repaired, cuff tear arthropathy, an unsuccessful shoulder replacement surgery, severe shoulder pain, a complete fracture of the shoulder joint, chronic shoulder dislocation or a shoulder joint tumor.

However, with growing reports of complications and fractures connected with the reverse shoulder implant, the FDA thought it necessary to issue a Biomet reverse shoulder recall.

In fact, the Journal of Shoulder and Elbow Surgery published a study that found those patients who experienced a fracture after they underwent shoulder replacement surgery had a six times higher rate of death within 30 days than the general population.

If you or someone you love has experienced a fracture after a reverse shoulder replacement and you suspect you might qualify under the Biomet reverse shoulder recall, you may benefit from speaking to an attorney.