Truliant 02-020-13-0240Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862320643), received between Aug 18, 2021 and Nov 15, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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.

• InjuryNov 15, 2022Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL LEFT SIDE TKA, THE 63 Y/O FEMALE PATIENT COMPLAINED OF A CLICKING SOUND IN HER KNEE, THE FEMUR SHOWED RADIOLUCENT LINES ON FILMS. SURGEON REVISED THE LOOSE FEMUR TO A SIZE 4 PS FEMUR. THERE WAS NO BREAKAGE OF A DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY WILL NOT ALLOW FOR THE RETURN OF THE EXPLANT. NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15797022 ↗
• InjuryJan 23, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, A (B)(6) PATIENT COMPLAINT OF PAIN AND HAD A REVISION DUE TO LOSE FEMUR. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURN.

  Patient problems: Failure of Implant

  MAUDE report 13330308 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2 YRS POSTOP THE INITIAL LTKA. THE (B)(6) MALE PATIENT HAD A REVISION DUE TO MUCH OSTEOLYSIS ESPECIALLY ON THE FEMUR. SURGEON ASSOCIATED THE EXTENSIVE OSTEOLYSIS WITH THE FEMUR FRACTURE. REVISED LEFT TIBIA AND FEMUR TO TRULIANT CC REVISION IMPLANTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 12338662 ↗