Truliant 02-022-45-6060Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305978), received between Dec 4, 2024 and Dec 4, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 42 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, JOINT PAIN, JOINT SWELLING, JOINT STIFFNESS, LIMITED RANGE OF MOTION, LOSS OF MOBILITY, MUSCLE TISSUE DAMAGE, TISSUE DAMAGE, DEVICE FAILURE NECESSITATING PAINFUL REVISION SURGERY; LIMITED ACTIVITIES, DAILY PAIN AND DISCOMFORT IN LEFT KNEE IMPACTING QUALITY OF LIFE. SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, AND OTHER UNDIAGNOSED INJURIES REQUIRING ONGOING MEDICAL CARE. FUTURE DAMAGES ALSO INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, HOME HEALTH CARE, LOSS OF EARNING CAPACITY, MENTAL AND EMOTIONAL DISTRESS, LOSS OF CONSORTIUM AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Implant Pain; Loss of Range of Motion; Osteolysis; Swelling/ Edema

  MAUDE report 20846539 ↗