The Biomet reverse shoulder implant has helped many people. But because of serious injuries, it is now subject to a recall.

In February 2017, the device’s manufacturer Zimmer Biomet issued a recall for its reverse shoulder products, stating that the devices have a higher fracture rate than what is listed on the label.

The Food and Drug Administration has called this a Class I recall. Class I is the most serious type of recall, issued when death or serious injury may occur as a result of the product’s use.

The FDA notes that the adverse health consequences of the Biomet reverse shoulder implant may include permanent loss of shoulder function, infection, and in some cases death.

In fact, the Journal of Shoulder and Elbow Surgery published a study that found that those patients who experienced a fracture after shoulder replacement surgery were six times more likely to die within 30 days. Death after shoulder replacement surgery often comes as a result of pulmonary, cardiac and abdominal problems.

In December 2016, Zimmer Biomet asked healthcare providers to quarantine any recalled devices they had in stock. The devices that have been affected by the quarantine and recall are those that were distributed between October 2008 and September 2015.

There were no instructions regarding patients who have already been implanted with the recalled devices.

What is a Biomet Reverse Shoulder Implant?

When a traditional shoulder replacement does not work because of large rotator cuff tears or arthropathy in which the tendons are too destroyed, a reverse shoulder replacement may be a better option.

The reverse shoulder implants are attached on the socket side of the joint, or the reverse of where it is naturally. The life-threatening fractures typically occur during surgery when the surgeon is prepping the bone to receive the implant.

Zimmer Biomet states that the serious fractures with the Biomet reverse shoulder implant are happening at a greater rate than they had expected and a higher rate than is listed on the box.

Arthritis Health lists several complications that are specific to reverse shoulder replacement surgery. In addition to bone fracture, joint dislocation or partial dislocation, called subluxation, can occur. It is possible that the new ball and socket may dislocate from one another. The risk of this might wane after time, but it will never completely go away.

Other possible complications are prosthetic misalignment, prosthetic loosening and joint instability. If the prosthetic is not correctly secured into the patient’s bone or if it is in some way misaligned, problems can occur.

The patient can also experience blood vessel or nerve injury in the surrounding tissue than can be harmful to their health. It is estimated that up to 4% of shoulder replacement recipients suffer some kind of nerve damage after surgery.

If you or a loved one has a Biomet reverse shoulder implant and has suffered a fracture, you may be entitled to compensation.