Truliant 02-022-35-3513Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862304384), received between Jan 24, 2023 and Jan 14, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 41 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN AND SYNOVITIS 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: Pain; Synovitis

  MAUDE report 21150287 ↗
• InjuryOct 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 4 YEARS AND 5 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 (B)(6) 2018: DIAGNOSIS: FAILED RIGHT TOTAL KNEE FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS A COPIOUS AMOUNT OF CAPSULAR SCAR TISSUE FROM POLYETHYLENE REACTION. THE POLYETHYLENE INSERT WAS REMOVED AND THERE WAS FOUND TO BE VISIBLE POLYETHYLENE WEAR WITHIN THE POLY TRAY. THERE WAS SEVERE OSTEOLYSIS AROUND THE DISTAL FEMUR AND PROXIMAL TIBIA WITH A LOOSE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS FOUND TO BE COMPLETELY LOOSE FROM THE CEMENT MANTLE WITH CEMENT STILL ADHERED TO THE DISTAL FEMUR WITH OSTEOLYSIS OF THE BONE ON THE BACK SIDE OF THE CEMENT. THERE WAS A PARTIALLY FIXED TIBIAL TRAY WITH OSTEOLYSIS UNDERNEATH THE TIBIAL TRAY. THE PATELLAR COMPONENT WAS ALSO REVISED.

  Patient problems: Discomfort; Failure of Implant; Osteolysis; Pain; Synovitis

  MAUDE report 18028074 ↗
• InjuryJan 24, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A MALE PATIENT, INITIAL LEFT KNEE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY I YEAR POST THE INITIAL PROCEDURE. A RADIOGRAPH REVEALED ¿FULL RADIOLUCENCY UNDER TIBIAL TRAY WITH SLIGHT MEDIAL MIGRATION¿. PLAINTIFF WAS DIAGNOSED WITH ¿FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AND RECALLED POLYETHYLENE INSERT¿. THUS, DUE TO WORSENING PAIN, INSTABILITY, SYNOVITIS, SWELLING, AND INABILITY TO WALK, THE PLAINTIFF UNDERWENT A LEFT KNEE REPLACEMENT REVISION SURGERY TO REMOVE THE DEFECTIVE DEVICE. DURING THE REVISION SURGERY, PLAINTIFF¿S ORTHOPEDIC SURGEON NOTED ¿TIBIAL INSERT WITH DAMAGE ALONG THE MEDIAL EDGE IN A LINEAR FASHION¿. UPON INFORMATION AND BELIEF, THE LOOSE COMPONENTS, SIGNIFICANT SYNOVITIS, AND PAIN WERE DUE TO DAMAGE TO THE POLYETHYLENE INSERT. THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, ONGOING PAIN, STIFFNESS, SWELLING, NUMBNESS, INABILITY TO BEND KNEE, INABILITY TO WALK UP STAIRS, INABILITY TO PERFORM ALL ACTIVITIES OF DAILY LIVING, CONTINUED

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Implant Pain; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16235653 ↗