Truliant 02-022-45-3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862305824), received between Jun 8, 2022 and Nov 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 20650993 ↗
• InjuryJun 18, 2024Unstable; Migration; Lack of Effect; Unstable; Migration; Lack of Effect

  IT WAS REPORTED THAT APPROXIMATELY 52 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, STIFFNESS, PAIN, ARTHRITIS, AND SCARRING. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthritis; Pain; Scar Tissue; Synovitis

  MAUDE report 19558470 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH KNEE REPLACEMENT STUDY, APPROXIMATELY THREE MONTHS POST INITIAL TKA, THE (B)(6) FEMALE PATIENT COMPLAINS THAT BECAUSE OF POST -OP INFECTIONS AND LOSS OF RANGE OF MOTION. PATIENT DOCUMENTS THAT SHE IS MORE CRIPPLED THAN BEFORE SURGERY. THE EVEN IS STILL ONGOING. PER CLINICAL STUDY CASE REPORT THIS EVENT IS POSSIBLY RELATED TO DEVICES AND TO PROCEDURE.

  Patient problems: Bacterial Infection

  MAUDE report 14632598 ↗