The Food and Drug Administration (FDA) issued a Class I Recall for LPS Diaphyseal Sleeves, commonly used in knee replacement surgeries, on February 15, 2013. A Class I Recall is the most severe recall issued by the FDA, indicating the potential for serious injury or death.
Complications with the LPS Diaphyseal Sleeve may result in a fracture that could lead to a loss of function of the limb, loss of the limb, infection, compromised soft tissue, or even death. So far, the FDA has received a total of 10 reports of incidents in which the device has malfunctioned. These reports include 6 fractures and 4 reports of loosening that may be attributed to this device. Adverse events associated with the LPS Diaphyseal Sleeve that may indicate serious complications include:
• change in position of the components,
• loosening, bending, cracking, fracture, deformation or wear of one or more of the components,
• fractures of the femur or tibia,
• pain, dislocation, subluxation, flexion contracture,
• decreased range of motion,
• lengthening or shortening of leg caused by improper positioning,
• possible loss of limb if complications occur
Keefe Law Firm handles complex medical device implant litigation throughout the nation. The firm’s offices are headquartered in New Jersey. For more information, please visit the firm’s defective joints website.