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.
More articles on devices:
AAOS & AHA request delay for new joint replacement payment model — 7 takeaways
Globus Medical names James Tobin to board of directors: 4 key notes
Surface technology for spine devices: Key trends & concepts
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
