Today the FDA reported that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder System Humeral Tray Model 115340 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,...
Bacterial Infections After Heart Surgery Using Allegedly Defective Heater-Cooler System – Litigation Update
Lawsuits have been and continue to be filed by individuals who have suffered bacterial infections following heart procedures involving LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices. The lawsuits allege that the manufacturer negligently designed the system thereby exposing open chest surgery patients to high levels of a bacteria, which in some...