Truliant 02-022-44-5013Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862305480), received between May 24, 2023 and Mar 4, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. 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; Discomfort; Pain

  MAUDE report 21519007 ↗
• InjuryOct 22, 2024Naturally Worn; Naturally Worn

  (B)(4) ARE ASSOCIATED WITH THIS CASE. IT WAS REPORTED THAT APPROXIMATELY 19 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. INITIAL SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO NOT BE A PART OF A RECALL.

  Patient problems: Insufficient Information

  MAUDE report 20509027 ↗
• InjuryOct 1, 2024Naturally Worn; Insufficient Device Problem Information; Lack of Effect; Naturally Worn; Insufficient Device Problem Information; Lack of Effect

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 18 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, MECHANICAL FAILURE OF RIGHT TOTAL KNEE EPLACEMENT, REQUIRING REVISON SURGERY; ARTHROFIBROSIS; INJURIES TO BONE AND TISSUE OF HIS RIGH TKNEE; BILATERAL KNEE PAIN, SWELLING AND REDUCED FUNCTIONING; LOSS OF RANGE OF MOTION, GREAT PAIN AND ANGUISH. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthrofibrosis; Implant Pain; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20345526 ↗
• InjurySep 20, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 51 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING, COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS, AND OTHER INJURIES PRESENTLY UNDIAGNOSED, MENTAL AND EMOTIONAL LOSS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SERIAL NUMBER (B)(6) IS CONFIRMED TO BE A PART OF RECALL NUMBER: Z-0023-2022.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Emotional Changes; Loss of Range of Motion; Osteolysis; Pain

  MAUDE report 20271060 ↗
• InjurySep 11, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  LEGAL CASE ¿ USA (MDL NO. 3044). RELATED (B)(4). (B)(4). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 24 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, STIFFNESS, DISCOMFORT, AND INSTABILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20189723 ↗
• InjuryJul 27, 2023Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE REVISION PROCEDURE THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2023. 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) 2023. DIAGNOSIS: FAILED RIGHT TOTAL KNEE REPLACEM,ENT SECONDARY TO WEAR OF THE BEARING SURFACE AND ARTHROFIBROSIS FINDINGS: FOUND EXTENSIVE SCAR TISSUE, ESPECIALLY IN THE LATERAL GUTTER AROUND THE LATERAL FEMORAL CONDYLE. THE EXTENSOR MECHANISM WAS ADHERENT TO THE FEMUR, BOTH MEDIALLY AND LATERALLY. THERE WAS A MODERATE SOFT TISSUE REACTION INVOLVING PRIMARILY THE POSTERIOR CAPSULE WITHOUT EXHUBERANT SYNOVITIS IN HIS MULTIPLY REOPERATED KNEE. NO COMPLICATIONS DURING THE PROCEDURE.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 17407627 ↗
• InjuryMay 24, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION A 68 Y/O MALE PATIENT HAD A REVISION RIGHT KNEE ON (B)(6) 2021. APPROXIMATELY 10 MONTHS AFTER THE FIRST REVISION THE PATIENT HAD A SECOND RIGHT KNEE REVISION ON (B)(6) 2022, DUE TO PAIN. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. 2ND REVISION OP REPORT - (B)(6) 2022. DIAGNOSIS: SYNOVITIS DUE TO POLYETHYLENE AND POLYMERIC DEBRIS THERE WAS A LARGE EFFUSION AND EXTENSIVE INFLAMED SYNOVIAL TISSUE CONSISTENT WITH POLYMERIC DEBRIS-INDUCED REACTION. ALL COMPONENTS ARE WELL-FIXED. THERE WAS A SMALL AREA OF OSTEOLYSIS OF THE POSTEROMEDIAL FEMUR. A COMPRESSIVE STERILE DRESSING WAS THEN APPLIED TO THE KNEE AND THE PATIENT BROUGHT TO RECOVERY IN STABLE CONDITION.

  Patient problems: Implant Pain; Joint effusion; Osteolysis; Synovitis

  MAUDE report 16991513 ↗