Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-03-17Open, ClassifiedLabeling Change Control

  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

  The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

• 2023-02-13Open, ClassifiedProcess control

  iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE

  Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

• 2015-10-26TerminatedLabeling design

  Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

  The labeling is missing the size/diameter information.

• 2015-02-04TerminatedDevice Design

  Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Intended for multiple uses. The TASP components are used to aid the surgeon in assessing the thickness of the articular surface required. The TASP construct is utilized while conducting a trial range of motion. The TASP consists of 3 parts: a TASP bottom, a TASP shim, and a TASP top. The shims come in varying thicknesses to allow trialing for specific Articular Surface implant thicknesses.

  Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991-22.

• 2013-05-02TerminatedLabeling mix-ups

  3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.

  U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.

• 2012-08-30TerminatedIncorrect or no expiration date

  3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.

  The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.