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Popular Medical Device Recall For Zimmer Biomet Comprehensive Reverse Shoulder System

On Feb. 16, 2017, Zimmer Biomet – a medical device manufacturing company – issued a Class I recall for its popular Comprehensive Reverse Shoulder System due to an excessive number of fractures in the humeral tray component. This system was implanted in patients undergoing shoulder arthroplasty surgery to help relieve joint pain and restore functionality and a greater range of motion. However, the components with model number 115340 began fracturing at a higher rate than anticipated, leading to the recall of 300 lot numbers distributed to patients in the last several years. This amounts to a total of 3,662 systems affected by the recall.

According to the FDA, as a result of the faulty components, patients may require additional surgery to correct the problem and could potentially suffer “permanent loss of shoulder function, infection, or rarely, death.” These adverse effects classify the recall under the FDA’s most serious type, Class I, which is reserved for cases with life-threatening consequences.

Zimmer Biomet is known for its innovative products, and this system was no exception. Their reverse shoulder system swapped the humeral head (ball) and the glenoid (socket) to the opposite sides of the glenohumeral joint. This type of surgery is especially helpful for patients with a severely torn rotator cuff, who would not otherwise be able to lift their arm above their head. Instead of relying on the torn rotator cuff to lift the arm, this surgery allows patients to use their deltoid muscle to do so. The humeral tray holds a polyethylene cup (plastic socket) at the top of the humerus bone and serves a vital role in the success of this system.

The company started contacting patients who received the recalled devices in late December and has since settled in court, but if you or a loved one has experienced a tray facture or other complications as a result of this total shoulder arthroplasty, then you have the right to seek out help.

Are You Affected?

Approximately 50,000 people in the U.S. undergo shoulder joint replacement surgery each year. If you or someone you love underwent shoulder replacement surgery between October 2008 and September 2015, then you may be affected by this recall. If so, contact Moore Law Firm in Mobile, Alabama for more information about the case and what we can do for you. Since 1985, our personal injury lawyers have been trusted by over 12,000 injury victims. Call (251) 445-7602 any day of the week to schedule a free consultation.