History of Zimmer Biomet’s Reverse Shoulder Device
The Zimmer Biomet Comprehensive Reverse Shoulder System is a surgically-implanted artificial shoulder device used to help restore arm movement in patients with rotator cuff tears who have developed a severe type of shoulder arthritis called arthropathy, and for whom traditional shoulder replacement is not an option. However, Zimmer Biomet’s shoulder implants have been linked to high fracture rates possibly leading to a permanent loss of shoulder function, infection, or in rare cases, death. In a study published in the Journal of Shoulder and Elbow Surgery in May 2016, researchers found that patients who suffered a fracture following shoulder replacement surgery had a “6-times higher incidence of death within 30 days than the general population.” According to the study report, the most common causes of death in these cases were pulmonary, cardiac and abdominal problems.
In February 2017, the U.S. Food and Drug Administration (FDA) issued a Class I recall of Zimmer Biomet’s Comprehensive Reverse Shoulder System, warning that the artificial shoulder implant may fracture at a higher rate than indicated in the device labeling, resulting in the need for revision surgeries. And for patients whose Zimmer Biomet shoulders fracture or otherwise fail, requiring surgery to remove or replace the device, there is a greater risk of infection, permanent loss of shoulder function, and possibly even death.
Reasons to File a Zimmer Biomet Shoulder Lawsuit
Patients who have suffered injuries from the recalled Zimmer Biomet shoulder system are filing lawsuits alleging that the company:
- Designed, manufactured and marketed a defective medical device
- Failed to properly research the long-term success of the reverse shoulder replacement system
- Knew about the potential risks associated with the reverse shoulder implant
- Failed to provide adequate warnings about the risk of complications from the shoulder implant
- Misrepresented the safety of the reverse shoulder device
What is the Comprehensive Reverse Shoulder System?
Zimmer Biomet’s Comprehensive Reverse Shoulder Humeral is specifically intended for patients who are not good candidates for traditional shoulder replacement, or for those who have had a failed shoulder replacement surgery. In most cases, patients receiving a Zimmer Biomet reverse shoulder implant have suffered rotator cuff tears, and so the implant is designed to use components in a reverse fashion than the normal operation of the shoulder joint, utilizing other muscles surrounding the rotator cuff to assist with movement. Unfortunately, alleged defects in the design of the shoulder implant make it prone to fracture, and in light of this risk, the FDA has classified the Zimmer Biomet shoulder recall as a Class I recall, warning that the implant may cause serious adverse health consequences or death when used by patients.
Injuries Linked to Zimmer Biomet Shoulder Implants
- Bone Loss
- Instability or weakness
- Fracture of the device
- Metal toxicity
- Device failure
- Other serious complication
How Do I Join the Zimmer Biomet Lawsuit?
Device manufacturing companies like Zimmer Biomet must be held responsible for any defects in the design of their medical devices, especially when these devices fail prematurely and cause serious injuries to patients, and patients adversely affected by a faulty medical device deserve to be compensated for their injuries. If you or a family member received a recalled Zimmer Biomet Comprehensive Reverse Shoulder System, and you have since suffered a major side effect or required revision surgery to remove the defective implant, you be entitled to financial compensation for your injuries, medical expenses and other damages. Contact a knowledgeable Zimmer Biomet shoulder injury lawyer as soon as possible to discuss your options for legal recourse.
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