A hip or knee replacement should last 10 to 15 years but the performance data on such is limited. Additionally, patients seldom ask about the device type, the manufacturer or why a particular manufacturer and device are selected. Yet, the TV commercials on recalls and litigation are numerous.
Several years ago, there were problems with metal-on-metal hips; hips in which the ball and joint are both metal. This type of hip was marketed by most of the major hip manufacturers. Excess wear and debris from the metal-on-metal can cause toxic reactions that destroy tissue and muscle. In many cases, the devices have to be replaced. The following is an example of how this affected one patient:
- A healthy 62 year old male undergoes a total hip replacement and the painful and time-consuming rehab.
- His quality of life improves; he goes back to work and resumes physical activities, such as biking and hiking.
- Three years later, the swelling and excruciating pain returns. Blood tests and examinations show that it is time for a replacement due to the metal-on-metal wear.
- Eventually, the device was recalled.
Manufacturers and the industry (hospitals, surgery centers, doctors, and associations) are slow to share data and HIPAA patient privacy concerns are another barrier. FDA routine monitoring is limited to adverse events involving a death or hospitalization attributed to the device. Many times, as with the metal-on-metal problem, it takes years for the FDA and manufacturers to recognize a problem, point fingers, complete additional studies, and take corrective actions. In the meantime, new surgeries are performed and more patients suffer from follow-on complications and surgeries. Costs soar.
Unfortunately, in December 2009, a registry requirement to track timely outcomes (pain, complications, recovery, patient satisfaction), safety, and longevity of a medical device was deleted from the then proposed Accountable Care Act; yet, the 2.3% federal tax on the medical devices was retained. Another problem is the close relationship that many physicians have with certain device manufacturers; the dollar amounts in device sales are huge.
Over 600,000 knees and 285,000 hips are replaced each year, and there are dozens of manufacturers, models, materials, constructs, and shapes. Unlike other products that you might have, there are no warranties, guarantees, or comparative data.
What should you do? Ask questions: What type of device? What material? What is the expected longevity? Who is the manufacturer? What is the percentage of recalls? Why was this particular device and manufacturer selected? Are there options? Although these questions might not prevent the metal-on-metal problem described above for the individual, the questions will press the industry to provide the safety, performance, and quality monitoring as well as transparency on the physician-manufacturer preferences. As patients, we trust our healthcare professionals to provide the best medical advice and services; yet, as with any complex medical procedure there are many variables, such as side effects, risks, safety, and, in the case of medical devices, performance and longevity.
 Meir, B. and Roberts, J. (2011, August 23)., Hip Implant Complaints Surge, Even as the Dangers Are Studied. New York Times. Retrieved from: http://www.nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html?pagewanted=1&_r=2&ref=health
 Sethi, Jahangir, Obremskey. The Affordable Care Act and Medical Devices: What you need to know as an Orthopaedic Surgeon. American Academy of Orthopaedic Surgeons. Retrieved from: http://www.aaos.org/news/aaosnow/feb11/advocacy2.asp
 Total Knee Replacement. American Academy of Orthopaedic Surgeons. http://orthoinfo.aaos.org/topic.cfm?topic=a00389
 Total HIP Replacement. American Academy of Orthopaedic Surgeons. http://orthoinfo.aaos.org/topic.cfm?topic=a00377