2007 and 2009 P.F.C. Recalls
In both 2007 and 2008, DePuy was forced to issue recalls of their P.F.C. knee systems. The first resulted from a defect in the replacement joint. The defect was a poor seal in the tibial insert of the rotating platform knee system. This seal could fail and allow oxygen to get into the joint. Over time, this had the potential to cause the artificial joints to wear out, break, and fail sooner than they should have.
The P.F.C. Sigma knee system was the subject of a recall in 2009 over a femoral component. The non-porous cruciate retaining femoral component of the Sigma knee system was discovered to potentially have a crack on the lateral side. If implanted in patients, these could have caused significant complications.
The year 2014 was not the best for DePuy artificial knee systems. The company saw three separate recalls. One was for over 100 S-ROM Noiles hinges. These were recalled over defects in packaging and sterility concerns. Later that same year, two recalls affected the Attune Intuition knee system. One recall was over a component that was susceptible to cracking, while the other led to taking 8,000 parts off the shelf over fractures in the device that caused pieces of the artificial knee to be left inside the patient.
2015 Attune Recall
The most notable of all of the company’s knee replacement system recalls occurred in 2015 when thousands of Attune knee systems and components had to be removed from the market. At issue was a surgical tool that came with the replacement joints. The tool had a tendency to break, leaving pieces inside the surgical site. Surgeons were not necessarily aware that part of the tool had broken off, leaving patients vulnerable to later complications.
2017 Sigma Recalls
With the most recent issue, DePuy faced criticism and resulting recalls over the Sigma HP PFJ cemented trochlear implant. When this component was used in patients, it led to much higher revision rates than would be expected as compared to other replacement parts and systems. At issue was the fact that the part could cause the artificial knee to become misaligned, unstable, and dislocated.
Complications from DePuy Knees
There are risks associated with the use of any knee replacement system, but with all of these recalls, DePuy has put many patients at risk. Complications caused by surgery, faulty components, surgical practices, or by a combination of all these factors can lead to significant harm to patients. These include bleeding and pain, infections and swelling, dislocation or movement of the joint, tissue damage, bone fractures, and a need for additional revision surgeries.
DePuy is not the only medical device company to face recalls of artificial joints, but in recent years, the number of devices affected has been significant for this manufacturer. Patients and doctors alike need to be aware of the potential for complications and the companies that have been forced to recall their devices.