MAUDE database reports “unusually high” rate of early failure related to total knee arthroplasty systems

MedDEV News. 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 total knee arthroplasty systems.

In the study, researchers said they reviewed clinical, radiographic and intraoperative findings for patients who received total knee arthroplasty systems and later required revision surgery.

Various hospital databases were examined for such patients with tibial loosening at the implant-cement interface. 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 up to 15% of the patients receiving total knee arthroplasty (relating to the various implant systems). Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface.

Analyzing different implant systems, researchers went on to indicate that - for certain systems - there had been up to 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.

Note: As the study does not give the exact numbers of cases done using the various total knee arthroplasty systems and the denominator is not known, the percentage of failure rates presented in this report cannot be seen as robust result but as serious indicator for the failure of these systems due to implant loosening and resulting in revision surgeries.