Truliant 02-022-35-2010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862304070), received between Jan 27, 2023 and Sep 16, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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.

• InjurySep 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 43 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE INSTABILITY, DIFFICULTY WALKING, ANTALGIC GAIT, SYNOVITIS, AND OTHER INJURIES PRESENTLY UNDIAGNOSED; INGOING MEDICAL CARE, ADDITIONAL SURGERIES; ANXIETY AND EMOTIONAL DISTRESS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Joint effusion; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 20223589 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SWELLING, PAIN, ACHINESS, GAIT IMPAIRMENT, AND DIFFICULTY WALKING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 19500819 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 49 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19498291 ↗
• InjuryFeb 26, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, THE 55-YEAR-OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019 AND PRESENTED WITH OTHER-MUA, 1 MONTH(S) AND 0 YEAR(S) POST-OPERATIVELY ON (B)(6) 2019. PATIENT WASN'T GETTING DESIRED ROM. PATIENT DID PHYSICAL THERAPY AND STILL ONLY HAD 0-77 ROM. ANKYLOSIS RIGHT KNEE, CLOSED MANIPULATION UNDER ANESTHESIA RIGHT KNEE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON 27-DEC-2020, AND THE ACTION TAKEN WAS OTHER - MUA RIGHT KNEE. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Ankylosis; Loss of Range of Motion

  MAUDE report 18785128 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY ONE YEAR POST INITIAL LEFT SIDE TKA, THIS 53 Y/O FEMALE PATIENT EXPERIENCED ARTHROFIBROSIS. PATIENT COMPLAINTS OF CONTINUING POST-OPERATIVE LEFT KNEE PAIN. SURGEON DISCUSSED RADIOGRAPHIC FINDINGS WITH THE PATIENT AS WELL AS TREATMENT OPTIONS. SURGEON BELIEVES PATIENT HAS SOME SCAR TISSUE ON THE MEDIAL ASPECT WITH SOME CREPITUS AND POINT TENDERNESS. SHE HAS FAILED CONSERVATIVE TREATMENT. SHE IS SCHEDULED WITH SURGEON AS SHE MAY BENEFIT FROM ARTHROSCOPY. THE EVENT WAS RESOLVED WITH PATIENT HAVING KNEE ARTHROSCOPY PLICA EXCISIONS AND SYNOVECTOMY (B)(6) 2018.

  Patient problems: Arthrofibrosis; Crepitus; Pain

  MAUDE report 16253779 ↗

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-