Truliant 02-022-55-4535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862317216), received between Oct 25, 2022 and Oct 25, 2022 — 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 25, 2022Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST INITIAL TKA, THE 64 Y/O FEMALE 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; Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 15666313 ↗