The study is titled “Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant-Cement Interface” and it was published in June 2017.
In the study, surgeons analyzed 15 patients who needed another knee surgery within 2 years of receiving an Attune knee replacement because they were suffering from pain, swelling, and limited mobility.
All 15 patients were diagnosed with loosening of the tibial baseplate at the implant-cement interface. In other words, there was almost no “cement” attaching the bottom of the implant to the patient’s bones.
The entire knee replacement is destabilized as a result of the tibial component of the Attune knee implant loosening. The only way to fix this complication is surgery to remove and replace the implant.
Patients with a loose knee implant are at risk of infections, nerve damage, bone fractures, limited mobility, and having one leg shorter than the other after undergoing another knee surgery.
The surgeons said they “encountered a high rate of debonding of tibial implant-cement interface,” and noted 21 reports of tibial loosening in the past two months alone. There are now at least 232 FDA reports of patients who had problems with an Attune knee implant. Furthermore, the surgeons blamed the failures on design flaws:
Several possible reasons include increased constraint, reduced cement pockets, and reduced keel rotational stabilizers. The tibial component, which has greater torsional loads, has lower surface roughness than femoral component.”
DePuy recently launched a new version called the “Attune S+” with bigger cut-outs on the underside of the tibial baseplate to improve bonding. No recall was issued for the original Attune knee implant.
At least 1 lawsuit has been filed in Alabama against DePuy on behalf of a person who needed surgery when their Attune knee implant loosened and failed prematurely. The lawsuit was filed in the Circuit Court of Tuscaloosa County, Alabama on September 13, 2017.
Source: Report: DePuy’s Attune knee seeing “unusually high” rate of early failure