Truliant 02-022-35-4512Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862304551), received between Feb 22, 2024 and May 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PERSISTENT AND INCREASING SIZE OF THE EFFUSION WITH WEIGHTBEARING PAIN. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PREOPERATIVE DIAGNOSIS: 1. FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR. POSTOPERATIVE DIAGNOSIS: 1. FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR. 2. ASEPTIC LOOSE FEMORAL COMPONENT. THE PATIENT IS A 61-YEAR-OLD GENTLEMAN WHO IS A FEW YEARS STATUS POST PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. HE HAS HAD PERSISTENT AND INCREASING SIZE OF THE EFFUSION RECENTLY WITH WEIGHTBEARING PAIN. INFECTION WORKUP HAS BEEN NEGATIVE. HE IS IN THE EXACTECH RECALL AND WAS FELT TO REPRESENT POLYETHYLENE WEAR AND OSTEOLYTIC DEBRIS. DESCRIPTION OF PROCEDURE: THERE WAS SYNOVITIS. SUBTOTAL SYNOVECTOMY WAS PERFORMED. THE PATELLA WAS EVERTED AND FOUND TO BE OXIDATED AND DELAMINATED. IT WAS THEN RESECTED JUST BENEATH THE CEMENT FOR A RESIDUAL THICKNESS OF 15MM. PREVIOUS 12 INSERT WAS REMOVED. FEMORAL COMPONENT WAS TESTED AT THIS POINT WITH A RETROGRADE DISIMPACTION AND EASILY POPPED OFF

  Patient problems: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 22044276 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 69 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PERSISTENT AND INCREASING SIZE OF THE EFFUSION WITH WEIGHTBEARING PAIN; OSTEOLYTIC DEBRIS, OXIDATED AND DELAMINATED PATELLA, ASEPTIC LOOSE FEMORAL. 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: Joint effusion; Osteolysis; Pain; Synovitis

  MAUDE report 20168497 ↗
• InjuryAug 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 3 Y/O MALE PATIENT'S RIGHT KNEE WAS REVISED. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING: CHAIN OF COMMAND DUE TO RECALL.

  Patient problems: Pain

  MAUDE report 19960245 ↗
• InjuryMay 17, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TKA, THE MALE PATIENT WAS REVISED FOR SUSPECTED POLY WEAR BUT NONE WAS OBSERVED. THE PATIENT WAS REVISED TO AN EXACTECH COMPLIANT POLY. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO FACILITY WILL NOT ALLOW RETURNED OF IMPLANTS.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19344515 ↗
• InjuryFeb 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 18759188 ↗

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-