Truliant 02-020-12-0325Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862314888), received between Feb 4, 2020 and Aug 12, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2022Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 57 YO FEMALE PATIENT, INITIALLY IMPLANTED ON (B)(6) 2021, UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR PAIN AND A LOOSE FEMUR. SHE WAS REVISED WITH COMPETITORS¿ DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCTS ARE NOT RETURNING AS THE CUSTOMER IS RETAINING THE DEVICES.

  Patient problems: Pain

  MAUDE report 15219053 ↗
• InjuryAug 24, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 14 MONTHS POST RTKA, THIS (B)(6) FEMALE PATIENT HAD A REVISION DUE TO RIGHT KNEE FAILED PRESS FIT FEMORAL COMPONENT THAT SHOWED LOOSENING ALONG THE ANTERIOR OF THE IMPLANT. PATIENT WAS DOWNSIZED FROM 2.5 TO A 2 CONDYLAR CONSTRAINED KNEE WITH A 14X80 STEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12361271 ↗
• InjuryFeb 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THIS (B)(6) FEMALE WAS INITIALLY IMPLANTED WITH A RIGHT TKA ON 7/8/2019. A TIBIAL COMPONENT REVISION ON (B)(6) 2019. CURRENTLY, APPROXIMATELY 6 MONTHS POSTOP THE INITIAL IMPLANT, THE PATIENT IS HAVING HER FEMORAL COMPONENTS REVISED DUE TO ASEPTIC LOOSING OF THE POROUS-INGROWTH FEMORAL COMPONENT. IT WAS NOTED THAT THE FEMORAL COMPONENT WAS LOOSE TO A MANUAL PUSH TEST. A LOCKING FEMORAL IMPACTOR WAS ATTACHED TO THE FEMORAL COMPONENT ON THE BONE AND A SLAP HAMMER WAS ATTACHED TO THE IMPACTOR. WITH ONLY A FEW STRIKES OF THE SLAP HAMMER, THE FEMORAL COMPONENT CAME OFF THE BONE. THE SURGEON NOTED THAT THERE WAS NO BONY INGROWTH ON THE FEMORAL COMPONENT; THERE WAS ONLY THE PRESENCE OF FIBROUS TISSUE THAT WAS ADHERING THE IMPLANT TO THE BONE. THE PATIENT'S FEMUR WAS PREPPED TO ACCEPT AN EXACTECH CC FEMORAL COMPONENT. A LOGIC RIGHT SIZE 2 CC FEMORAL COMPONENT WITH 14X120 WAS CEMENTED INTO PLACE. A SIZE 2F-2.5T X 15MM TRANSITION TIBIAL INSERT WAS ALSO IMPLANTED AND FOUND TO BE STABLE. THE SPINE STIFFENING SCREW WAS SEATED, AND THE PROCEDURE WAS OTHERWISE COMPLETED WITHOUT INCIDENT. NO OTHER IMPLANTS WERE REMOVED DURING THIS PROCEDURE. THE PATIENT LEFT THE OR IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 9666006 ↗