Truliant 02-020-13-0330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862314673), received between May 6, 2022 and Nov 11, 2024 — 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 11, 2024Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4) PATIENT ID: (B)(6). AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 2 YEARS AND 1 MONTH AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2019. 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. AS DIRECTED BY QA MANAGEMENT: THIS LEGAL COMPLAINT FOR POLYETHYLENE ISSUES OCCURRED IN THE US. THE EVENT DID NOT OCCUR IN, NOR IS IT REPORTABLE FOR AUSTRALIA, BRAZIL, CANADA, EEA/EU, JAPAN, TAIWAN, OR GREAT BRITAIN, EXCLUDING NORTHERN IRELAND. THEREFORE, ONLY THE US REPORTABILITY DETERMINATION WILL BE ASSESSED. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND IN

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20651045 ↗
• InjurySep 19, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO A LOOSE FEMUR. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER MEDICAL HISTORY/PATIENT INFORMATION PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Balance Problems; Discomfort; Emotional Changes; Failure of Implant; Joint effusion; Osteolysis; Pain

  MAUDE report 15447826 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL TKA, THIS FEMALE PATIENT WAS REVISED DUE TO PAIN. A MRI AND CT SCAN DID NOT SHOW ANYTHING SIGNIFICANT PER SURGEON BUT SUSPECTED POLY WEAR AND POTENTIALLY AN ISSUE WITH THE TIBIA. HOWEVER DURING SURGERY NO SIGNIFICANT POLY WEAR WAS NOTED AND THE TIBIA WAS NOT LOOSE. THE FEMUR HOWEVER WAS FOUND TO BE DE-BONDED FROM CEMENT MANTLE. IT WAS STILL IN ORIGINAL POSITION BUT WAS EASILY WORKED LOOSE WITH MINIMAL STRIKES WITH A FLEXIBLE OSTEOTOME. THE SURGEON FELT THE NEED TO SWITCH TO COMPETITOR'S DEVICE FOR THE REVISION IMPLANTS. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. NO FURTHER INFORMATION AVAILABLE. IMAGES AND PHOTOS RECEIVED. EXPLANTS NOT AVAILABLE TO THE REP.

  Patient problems: Pain

  MAUDE report 14307913 ↗