Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant–Cement Interface

Abstract

A novel design total knee arthroplasty (TKA) system has been introduced to improve patient outcomes and increase longevity. However, we have encountered a high rate of debonding of tibial implant-cement interface. In addition, multiple reports have been filed in Manufacturer and User Facility Device Experience database (MAUDE) with the same mechanism of failure. Therefore, we evaluated: clinical, radiographic, and intraoperative findings of patients who received this system and required a revision surgery, and findings from MAUDE database compiled to this date. We reviewed three hospital databases for patients who had revision TKA for tibial loosening at the implant-cement interface. This yielded 15 cases with a mean age of 61 years (range, 47-84). All patients received a novel knee system at another institution. Radiographic analysis was performed by treating orthopaedist. The MAUDE database was reviewed for reports of aseptic failure. Patients presented with pain on weight bearing, effusion, and decreased range of motion (ROM) within 2 years after surgery. Radiographic evaluation demonstrated loosening of the tibial components in 2 of 15 knees. This included cruciate retaining, posterior stabilized, fixed bearing, and rotating platform bearing designs. Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface. Femoral and patellar components were well fixed. There were 21 reports of tibial loosening at the implant-cement interface in MAUDE database in the past 2 months alone. Numerous other tibial failures were reported; however, the mechanisms of failures were not specified. Tibial component loosening is a rare complication of cemented TKA at short-term follow-up. 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. We believe that this complication is

A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design

“…One paper reported more revisions supposedly related to cement implant debonding for the ATTUNE, 15 however this was a case series without reporting the size of the series in which the findings were made, making it of limited scientific value. 35 , 36 Potential problems with cement adherence to the undersurface of the tibial plateau have also been presented by others, 37 , 38 and for other modern tibial components of TKA implants.…”

Analysis of the Attune tibial tray backside

“…Future analysis is required in order to better address the role of both the design and cement features in order to understand fully the phenomenon of debonding at the implant-cement interface observed in a previous study. 17…”

“…Recently, early aseptic failures at the implant-cement interface in the Attune TKA system (DePuy, Warsaw, Indiana) were reported in a retrospective study without a control group; 17 the authors found a high rate of early aseptic tibial loosening. The study was based on data from the Manufacturer and User Facility Device Experience (MAUDE) database, 18 which is of limited use because it is a self-reported manufacturer database.…”

Unacceptable failure rate of a ceramic-coated posterior cruciate-substituting total knee arthroplasty

“…Although superior surface technology that minimizes potential allergic reactions and enhances wear characteristics is promising, the surgical community must consider more than just potential wear characteristics such as adhesion. Second, there are other noncoated implants currently on the market with early tibial tray failure that have gone through geometric surface modification to enhance cement adhesion that may need closer scrutinizing, although none have shown a sustained failure rate similar to this report [26] .…”