Truliant 02-020-12-0235Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862314796), received between Aug 16, 2021 and Jan 6, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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.

• InjuryJan 6, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 13 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, LOOSENING, INSTABILITY, AMBULATION OR POSTURAL DIFFICULTIES, JOINT LAXITY, FAILURE OF IMPLANT, SCAR TISSUE, SYNOVITIS, PAIN AND SWELLING/ EDEMA. 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: Ambulation or Postural Difficulties; Failure of Implant; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 21080173 ↗
• InjurySep 14, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE PATIENT COMPLAINED OF SEVER PAIN, A POSSIBLE LOOSE FEMUR, AND WAS REVISED TO A COMPETITOR'S PRODUCT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Failure of Implant; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 15419116 ↗
• InjuryAug 16, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8 MONTHS POSTOP THE THIS (B)(6) Y/O FEMALE PATIENT¿S INITIAL LTKA, A REVISION WAS COMPLETED ON A PRESSFIT POROUS FEMUR. THE SURGEON THOUGHT THE FEMUR LOOKED LOOSE AND WOULD HAVE TO BE REVISED. THE PRESSFIT 3.5 FEMUR POROUS WAS REMOVED AND REPLACED WITH A SIZE 3 CONDYLAR CONSTRAINED FEMUR WITH A 18 X 80 STEM. PLACED A SIZE 3/17MM PS INSERT. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 12329334 ↗