Truliant 02-020-12-0345Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862314925), received between Apr 9, 2024 and Feb 26, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Loss of Osseointegration

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL TKA, THE PATIENT HAD PAIN STARTING A FEW WEEKS AFTER SURGERY. PATIENT IS DISSATISFIED WITH IMPLANT FUNCTION. TIBIA WAS LOOSE WITH ONLY FIBROUS INGROWTH. FEMUR ALSO HAD MINIMAL BONE INGROWTH. 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. SALES REP WAS UNABLE TO OBTAIN PHOTOS AND X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO RECALL HOSPITAL WILL NOT RELEASE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Pain

  MAUDE report 24456156 ↗
• InjuryApr 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A 58 YO MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED TO THE SURGEON FOR PAIN IN THE KNEE DUE TO LOOSE FEMUR AND RECALLED LINER. THEY WERE REVISED TO A CONSTRAINED SIZE 4 LEFT FEMUR WITH A DISTAL 5 MM AUGMENT ON THE LATERAL SIDE WITH A 20 X 1 2. 4.5/13MM PS INSERT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THE PATIENT HAS A LAWYER DUE TO THE LINER RECALL AND EVERYTHING WAS GIVEN TO THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Pain

  MAUDE report 19073296 ↗