Truliant 02-022-45-4040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862305886), received between Oct 18, 2024 and Jan 23, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  ADDITIONAL INFORMATION RECEIVED FROM LEGAL ON 07AUG2023. AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2020. APPROXIMATELY 2 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON 8 NOV 2022. DIAGNOSIS: FAILED RIGHT TKA; RIGHT KNEE INSTABILITY WITH VARUS STRESS FINDINGS: THE QUAD WAS ADHERENT ANTERIORLY AND A QUADRICEPSPLASTY WAS REQUIRED TO FREE THE EXTENSOR MECHANISM. THE FEMORAL COMPONENT WAS WELL FIXED BUT INTERNALLY ROTATED. THE TIBIAL TRAY WAS IN SLIGHT VARUS, BUT THERE WAS A NOTICEABLE GAP AT THE CEMENT BONE INTERFACE CONCERNING FOR LOOSENING. ORIGINAL DESCRIPTION SUMMARY: LEGAL CASE ¿ (B)(6). IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6) 2022. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. UNABLE TO LOCATE SURGEON/PATIENT/SERIAL NUMBER IN EBI. NO SERIAL NUMBERS AVAILABLE. HISTORICAL RECORD AND SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER

  Patient problems: Discomfort; Implant Pain; Joint Laxity; Joint effusion; Scar Tissue; Swelling/ Edema

  MAUDE report 21218077 ↗
• InjuryOct 18, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2020. APPROXIMATELY 2 YEARS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND LEFT KNEE REVISION ON (B)(6) 2022 DUE TO ACCELERATED AND PREVENTABLE WEAR. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20481895 ↗