MicroPort Orthopedics has issued a voluntary class 1 recall of its PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck (Part 1254), according to an FDA notice.
Here are five key notes:
1. The company has received reports of an unexpected rate of fractures after surgery related to this modular neck, which is used in hip joint replacement procedures.
2. The FDA defines a class 1 recall as "the most serious type of recall [that] involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
3. An acute fracture following hip surgery typically requires revision surgery so as to remove and replace the neck and stem components.
4. The company has instructed patients to seek immediate medical treatment if they experience any sudden onset of severe pain in their hip postoperatively.
5. MicroPort has also instructed distributors and hospital staff, including risk managers and surgeons, to locate all affected product identified in the recall letter and to return the product to MicroPort Orthopedics' distribution center.