Truliant 02-022-55-2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862317100), received between Oct 15, 2019 and Oct 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2019Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PER PROTOCOL, EXACTECH TOTAL KNEE COMPONENTS EXPLANTED IN A RIGHT REVISION TOTAL KNEE PROCEDURE WERE OBTAINED, WASHED, STERILIZED, AND WILL BE RETURNED TO EXACTECH FOR EVALUATION. THE INDEX RIGHT TKA PROCEDURE WAS DONE ON (B)(6) 2019. THE REVISION PROCEDURE, DONE ON (B)(6) 2019 WAS UNDERTAKEN FOR ASEPTIC LOOSENING OF THE TIBIAL COMPONENT ¿02-022-55-2525. DURING THE REVISION, IT WAS NOTED THAT THE TIBIAL COMPONENT DID NOT HAVE BONY INGROWTH ON THE MEDIAL SIDE; HOWEVER, SOME BONY INGROWTH WAS APPRECIATED ON THE UNDERSIDE OF THE TIBIAL TRAY, LATERALLY. THEREFORE, IT WAS NECESSARY TO USE A SMALL SAW TO CUT THROUGH THIS LATERAL BONY INGROWTH, WHICH WAS DONE. AN EXACTECH TIBIAL EXTRACTOR WAS THEREAFTER ATTACHED TO THE TIBIAL TRAY AND WITH A SLAP HAMMER ATTACHED WAS USED TO EXTRACT THE TIBIAL TRAY FROM THE TIBIA. EXACTECH CEMENTED TIBIAL COMPONENTS WERE UTILIZED FOR THE REVISION, INCLUDING A 2.5F/1.5T TIBIAL TRAY, TWO 5MM, SIZE 1.5 ½-BLOCK TIBIAL AUGMENTS, A 14X120 SPLINED STEM, STEM EXTENSION SCREW, 29MM TIBIAL CONE, AND A 2.5, 11MM PSC TIBIAL INSERT. THE REVISION PROCEDURE WAS CARRIED OUT UNEVENTFULLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT

  Patient problems: Failure of Implant; No Information

  MAUDE report 9195320 ↗