Truliant 02-022-35-3012Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862304285), received between Jul 5, 2023 and Feb 25, 2025 — classified as 8 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.

1 other recall cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA. THE PATIENT COMPLAINED OF PAIN AND WAS REVISED APPROXIMATELY 38 MONTHS LATER DUE TO A LOOSE FEMUR, PROSTHETIC WEAR AND RECALLED POLY. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. 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; Pain

  MAUDE report 21460005 ↗
• InjuryDec 13, 2024Unstable; Unstable

  AS REPORTED, APPROXIMATELY 2 YEARS AND 10 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO SWELLING, PAIN, AND INSTABILITY. THE INDICATIONS FOR REVISION WERE NOT SUBJECT TO ONLY POTENTIAL POLY WEAR. THE PATIENT WAS REVISED TO A 17MM PSC POLY. THE FEMORAL AND TIBIAL COMPONENTS WERE DEEMED STABLE AND WERE NOT REVISED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint effusion; Pain; Swelling/ Edema

  MAUDE report 20928785 ↗
• InjuryAug 28, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, DEBONDED FEMORAL. REVISION 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.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Joint Laxity; Loss of Range of Motion; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20084652 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 25 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19459795 ↗
• InjuryApr 24, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS 6 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 8 MONTHS POST OP INITIAL SURGERY. THE PATIENT RETURNED TO SURGEONS OFFICE WITH COMPLAINTS OF POPPING, CLICKING, PAIN, AND DISSATISFACTION WITH THEIR TKA. UPON EXAMINATION THE PATIENT PRESENTED WITH SLIGHT INSTABILITY. THE PATIENT WAS SCHEDULED FOR A REVISION TKA POLY SWAP WITH SYNOVECTOMY. THE REVISION WAS PERFORMED ON (B)(6) 2024 AND THE PATIENT UNDERWENT A SYNOVECTOMY AND TIBIAL POLY INSERT SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES NOT RETURNING, DISCARDED AT THE FACILITY.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity

  MAUDE report 19177858 ↗
• InjuryFeb 13, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A BILATERAL TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, APPROXIMATELY AFTER 1 YEAR AND 4 MONTHS REPORTED REVISION EXPERIENCED TO THE RIGHT KNEE ON (B)(6) 2022. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18696444 ↗
• InjuryJul 12, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 THEN A LEFT KNEE TWO STEP REVISION FOR INFECTION ON (B)(6) 2020 AND THE SECOND STEP ON (B)(6) 2020. THIS INFORMATION WAS DERIVED FROM THE REVISION OPERATIVE REPORT OF (B)(6) 2021, WHICH STATES THAT THE PATIENT WAS STATUS POST A TWO-STEP REVISION FOR INFECTION. IT IS REASONABLE THAT THE THREE-MONTH GAP BETWEEN THE TWO REPORTED PROCEDURES IS A TWO-STEP SURGICAL TREATMENT PLAN FOR INFECTION AND THE SALES INFORMATION SHOWS THAT THE PATIENT RECEIVED A NEW INSERT ON (B)(6) 2020. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 17306506 ↗
• InjuryJul 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND CLAIMS TO HAVE PAIN, SUFFERING, DIFFICULTY WALKING, AND REQUIREMENT OF FUTURE SURGERIES. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 17259828 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-