Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes’ Attune total knee arthroplasty system is experiencing an “unusually high” rate of early failure related to its tibial components, according to a new study.
The study, recently published in the Journal of Knee Surgery, explored a number of FDA reports to its Manufacturer and User Facility Device Experience database related to the Attune knee. A search of the MAUDE system results in a total of 232 reports related to the Attune TKA.
In the study, researchers said they reviewed clinical, radiographic and intraoperative findings for patients who received the Attune system and later required revision surgery.
A total of 3 hospital databases were examined for such patients with tibial loosening at the implant-cement interface, producing a total of 15 cases.
“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,” study authors wrote. “Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface.”
Researchers went on to indicate that there had been 21 reports of tibial loosening at the implant-cement interface to MAUDE in the past 2 months alone, with “numerous other tibial failures” also reported without the mechanism for failure specified.