An example of this arose recently in a prosthetic knee device approved by the FDA for use with bone cement. However, the device was designed with the idea that bone cement would not be necessary because the bone could grow through porous holes in the device(bony in growth). Since the FDA only approved the device for cemented use, the manufacturer was prohibited from marketing the device for bony in growth. However, the physicians knew of the bony in growth potential and were actively implanting the device without bone cement. When the device ultimately failed, the physicians were upset with the manufacturer for not informing them of this limitation in advance.
The FDA requires “device user facilities” and manufacturers and distributors to promptly notify the FDA about device-related failures or events that may have caused a death, serious injury, or illness. These reports called Medical Device Reports (MDR’s), are required to ensure that the most serious problems will be identified to the user. Typically, problems with medical devices fall into one of three broad categories: (i) Device problems; (ii) Use problems; and (iii) Clinical problems.
Each year, the FDA receives approximately 100,000 reports through the MDR route and another 5,000 device reports through the voluntary MedWatch route. Nurses submit about 25% of the voluntary reports with biomedical engineers submitting 21% of these reports. Physicians only submit about 8% of these reports.