Truliant 02-022-35-5013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862304650), received between Jul 19, 2022 and Dec 3, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 30, 2021Class IIOpen, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0023-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 72 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. A REVISION PROCEDURE HAS NOT BEEN PERFORMED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20832711 ↗
• InjuryJul 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 57 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS EFFUSIONS, PAIN, AND FEMORAL LOOSENING. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Pain

  MAUDE report 19720529 ↗
• InjuryJun 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEARPAIN, STIFFNESS, DISCOMFORT, WEAKNESS, NEGATIVELY AFFECTED QUALITY OF LIFE, ADDITIONAL REVISION SURGERY, PHYSICAL ACTIVITIES LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Implant Pain

  MAUDE report 19477183 ↗
• InjuryApr 17, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY LEGAL TEAM, APPROXIMATELY ONE YEAR POST INITIAL BILATERAL TKA, THE 75 Y/O MALE PATIENT HAD A RIGHT KNEE REVISION FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16751583 ↗
• InjuryJul 19, 2022Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn; Unstable; Detachment of Device or Device Component; Device Dislodged or Dislocated; Naturally Worn

  THIS 79 YEAR OLD, MALE PATIENT HAD A RIGHT KNEE TKA ON (B)(6) 2019. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED ON (B)(6) 2022 DUE TO THE CURRENT INSERT NOT BEING FULLY LOCKED IN AND BECOMING DISASSOCIATED. THE SURGEON REVISED THE PATIENT TO A SIZE 5/19MM. THERE IS NO REPORTED BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Osteolysis; Swelling/ Edema

  MAUDE report 15051707 ↗