Truliant 02-020-14-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862315113), received between Sep 29, 2022 and Jul 10, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. 4 YEARS FOLLOWING, THE PATIENT EXPERIENCED LIMITED RANGE OF MOTION WITH PAIN IN THE RIGHT TKA, SUBJECT IMPACTED THE KNEE 2 MONTHS PRIOR AND UNDERWENT PHYSICAL THERAPY REHABILITATION. SUBSEQUENTLY, THE PATIENT HAS NOW EXPERIENCED ASEPTIC FEMORAL LOOSENING FOUND ON THE RADIOGRAPHS. PATIENT DEIGNS PAIN BUT INDICATES THAT ROM IS MORE OF A CONCERN; AT THIS VISIT WAS 0-85 DEGREES FLEXION. AS A RESULT, APPROXIMATELY 5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT IS AGAIN UNDERGOING PHYSICAL THERAPY REHABILITATION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 22471685 ↗
• InjuryNov 4, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A 70 YO FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED WITH EXACTECH TRULIANT TOTAL KNEE SYSTEM ON (B)(6) 2021, WAS SEEN POSTOPERATIVELY IN (B)(6) 2021 WITH COMPLAINTS OF ONGOING PAIN IN HER KNEE, ESPECIALLY DURING AND FOLLOWING PHYSICAL THERAPY. AT THAT TIME, X-RAYS SHOWED QUESTIONABLE INGROWTH IN THE FEMORAL COMPONENT. THE PATIENT¿S ORTHOPEDIST DIRECTED HER TO STOP THE PHYSICAL THERAPY TO SEE IF THE BONE MIGHT HEAL AND RETURN FOR NEW X-RAYS IN A FEW WEEKS. IN (B)(6) 2022 DURING ANOTHER APPOINTMENT WITH HER SURGEON. X-RAYS SHOWED A FAILURE OF INGROWTH OF THE FEMORAL COMPONENT AND THE DOCTOR INFORMED HER SHE WOULD NEED TO HAVE REVISION SURGERY IN CONNECTION WITH BOTH THE FEMORAL AND TIBIAL COMPONENTS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, APPROXIMATELY 10 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE PATIENT NOW WALKS WITH A CANE AND HAS BEEN ABLE TO RESUME MOST OF HER ACTIVITIES, DESPITE A CONTINUING LIMP. SHE NO LONGER NEEDS TO ATTEND PHYSICAL THERAPY AND HAS BEEN DISCHARGED BY THE THERAPIST.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 15728316 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021, PRESENTED TO THE CLINIC WITH PAIN AND INSTABILITY. THE MECHANICAL CUTS APPEARED GOOD ON X-RAY BUT THE PATIENTS MCL APPEARED TO BE NOT FUNCTIONING WITH NOTABLE GAPPING MEDIALLY. A REVISION WAS PERFORMED ON (B)(6) 2022, APPROXIMATELY 9 MONTHS POST THE INITIAL IMPLANT PROCEDURE. LATERAL RELEASES AND THICKER POLY DID NOT SOLVE THE MID FLEXION INSTABILITY, SO THE PREVIOUS POROUS FEMUR WAS CONVERTED TO A STEMMED CC FEMUR WITH A CC INSERT. DURING THE PROCEDURE, A SLIGHT CRACK OF THE MEDIAL CONDYLE WAS NOTED DURING IMPACTION OF THE FEMUR, WHICH OCCURRED DURING IMPACTION AND ADJUSTING ROTATION. THE NEW IMPLANTS WERE STABLE WITH GOOD ROM AND THE INSTABILITY WAS SIGNIFICANTLY BETTER PER THE SURGEON. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN. PRODUCT NOT RETURNING - EXPLANTS NOT AVAILABLE.

  Patient problems: Implant Pain

  MAUDE report 15502468 ↗