Medical device manufacturer Zimmer Biomet has recalled more than 3,000 shoulder implants due to a high fracture rate inside of patients, leading to severe injury and revision surgery.
“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death,” according to a Recall Alert by the agency.
This is the second time the company has had to recall this type of shoulder implant, known as the Comprehensive Reverse Shoulder system.
The device is surgically implanted to help restore arm movement, especially in patients with rotator cuff tears who have developed severe shoulder arthritis. It is also used in patients with a previously failed shoulder joint replacement.
Shoulder Implants Keep Fracturing Years After First Recall
According to the FDA, “Zimmer Biomet is recalling the Comprehensive Reverse Shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
Shoulder implants are designed to replace the typical shoulder anatomy. The recalled Zimmer Biomet reverse shoulder implant is intended to work, and is marketed as being, more effective than traditional shoulder implants. The reverse shoulder works by relying on the patient’s deltoid muscle rather than the rotator cuff. The deltoid muscle is used to both stabilize and operate the patient’s arm.
Surgery for reverse shoulder implants has become the third biggest market for joint reconstruction.
A recall notice was first distributed by Zimmer Biomet in December 2016 requesting that health care practitioners across the nation quarantine any remaining stock of Comprehensive Reverse Shoulder systems.
More than 3,662 units have been sold across the country and no guidance has yet been provided by the manufacturer about how patients with the recalled Zimmer shoulder implants should respond.
This is the second recall for this shoulder implant, leading some to wonder if it should be considered a defective medical device.
The Biomet Comprehensive Reverse Shoulder implant was previously recalled in 2010 after the company, which was later purchased by Zimmer, received complaints about the implant fracturing. Now that six years have passed, the shoulder implant has been recalled again.
Both shoulder implant recalls had to do with the humeral tray, a portion of the product that has a high rate of fracture risk after it has been implanted.
How Do I Know If I Have One of the Recalled Zimmer Shoulder Implants?
Typically, patients are not familiar with the type of implant they have received so if you have questions about whether or not you are affected by the Zimmer shoulder implant recall, you should consult with your physician. Patients may be at severe risk of serious injury if they have a Zimmer Biomet shoulder implant.
Shoulder implant fractures can lead to revision procedures that are extremely invasive and could cause adverse problems such as infection, permanent loss of shoulder function, or death. While revision surgery may be an option, that procedure comes with a high risk for the patient losing all use of the shoulder.
If you suffered a shoulder implant fracture and had to undergo revision surgery, you may have a legal claim. The defective medical device lawyers at Bradley/Grombacher have experience helping patients with medical device problems. Fill out the form on this page now for a FREE case evaluation.