Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
It appears that DePuy Synthes, a subsidiary of Johnson & Johnson, is providing its sales reps with talking points that push back against growing concerns over problems with DePuy Attune knee replacement systems, which have been linked to reports of premature failure and complications by surgeons nationwide.
DePuy created a presentation for its sales reps, which addresses mounting worries in the medical community. The presentation appears to specifically focus on a newer version of the implant, the DePuy Attune S+ knee, which boasts a better tibial baseplate design, despite the fact the manufacturer has continued to maintain that there is nothing wrong with the original knee implant.
Although the DePuy just introduced the Attune system in 2012, high numbers of knee replacement complications have been linked to the implant in post-marketing adverse even reports.
Earlier this year, in a report published in the Journal of Knee Surgery, researchers noted a spike in DePuy Attune knee tibial loosening and failures, raising concerns about problems at the implant-cement interface.
As of June 2017, the FDA adverse event reporting system already had about 1,400 incidents of early DePuy Attune knee failures, including at least 633 cases where individuals required revision surgery.
The presentation prepared by the manufacturer highlights joint registries that indicate that the DePuy Attune S+ knee is performing on par or better than other knee replacement systems when it comes to failures or other complications. However, it also notes that aseptic loosening is identified as an industry-wide problem for knee replacement systems, and is the leading cause of revision surgery.
“Estimated 162K patients worldwide revised for aseptic loosening over 10 years, 63.5K in US,” the slides note. DePuy tells its sales reps that patients may face pain, swelling, stiffness, clicking in the knee, occupational disability and impairment.
The presentation indicates that the leading operative factors for the knee failures are body mass index, implant alignments and cementing technique.
The sales reps are instructed to inform doctors that they should be aware that the patient’s size and body mass index are a major factor in problems and can affect the alignment of tibial and femoral components. They are also told to tell doctors that cementing problems, which have been widely reported with some knee implants, are often due to the surgeon’s technique and experience, even though many reports have indicated that the cements are just failing.
However, the highlight of the Attune S+ technology is it’s “macrolock” and “microblast” surfaces on the tibial base plate, which are specifically designed to increase cement fixation. Some say this suggests DePuy knows there was a problem and is trying to fix it, while officials have said they are simply trying to make a good product better.
Amid increasing reports of failures, a growing number of DePuy Attune knee lawsuits are being pursued by individuals who had their implant fail only a few years after joint replacement surgery.