Some 50,000 shoulder replacement surgeries are done every year in the U.S. It is often recommended for those who are experiencing severe pain or stiffness due to arthritis or degenerative joint diseases.
However, patients who develop a complex type of shoulder arthritis due to large rotator cuff tears from injuries or degenerative issues require a reverse shoulder replacement procedure according to the American Academy of Orthopaedic Surgeons. The procedure is done to help restore motion, strength, and function, allowing patients to return to normal activity levels including sports
During a traditional shoulder replacement surgery, the shoulder’s humeral head is replaced with a metal ball, while a new plastic surface is added to the glenoid also known as the shoulder socket. In a reverse shoulder surgery, the metal ball is attached to the glenoid/shoulder socket while the plastic surface is fixed to the upper end of the humeral head supported by a metal stem implanted in the humerus/arm bone.
What is the Smith & Nephew PROMOS Modular Shoulder System?
Developed to restore function and relieve pain, the Smith & Nephew PROMOS Modular Shoulder System is indicated for both traditional and reverse shoulder replacements. A reverse shoulder replacement would be recommended for those who have:
- A severely torn rotator cuff that cannot be repaired
- Cuff tear arthropathy
- A previous unsuccessful shoulder replacement
- Complex f, actures or chronic dislocations of the shoulder joint
- A complex fracture of the shoulder joint
The modular system was designed to allow the surgeon the flexibility of performing either a traditional or a reverse procedure as needed once they are in the operating room.
Issues with the Smith & Nephew PROMOS Modular Shoulder System in Reverse Shoulder Replacements leads to new injuries
A serious issue has begun to be reported about the Smith & Nephew PROMOS Modular Shoulder System when used for reverse shoulder replacements procedures. Some reverse shoulder replacement patients are experiencing fractures due to the stem of the device breaking after it has been implanted in the upper arm bone.
This major device defect can lead to a series of health concerns including:
- Infection and Pain
- Temporary or permanent loss of shoulder function
- The need for revision surgeries
Related Smith & Nephew PROMOS Shoulder System Recalls
This is not the first issue with a Smith & Nephew PROMOS shoulder product. The U.S. Food and Drug Administration issued a Class II recall for the Smith & Nephew PROMOS Inclination Set in 2010. At the time, it was found that the company’s inclination set screws were fracturing causing serious injuries and major revision procedures. The series of inclinations sets were pulled from the market in the U.S., Asia, and Europe.
How can Meyers & Flowers help
The Meyers & Flowers team is dedicated to protecting the right of those injured by defective and dangerous medical devices. If you or a family member have been injured by the Smith & Nephew Promos Modular Reverse Shoulder system, we encourage you to contact us to explore your legal options.