Truliant 02-022-35-5010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862304629), received between Oct 25, 2019 and Mar 7, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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.

• InjuryMar 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INFLAMMATION, JOINT EFFUSION, AND PAIN. INITIAL SURGERY AND 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: Inflammation; Joint effusion; Pain

  MAUDE report 21548462 ↗
• InjuryJul 10, 2024Naturally 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 APPROXIMATELY 2 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, RE-REVISION SURGERY, SYNOVITIS, POST-REVISION INFECTION, IRRIGATION AND DEBRIDEMENT, AND PLACEMENT OF ANTIBIOTIC BEADS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 19716720 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 54 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE 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 19463814 ↗
• InjuryMar 13, 2024Naturally Worn; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain

  MAUDE report 18894031 ↗
• InjuryJul 18, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2018. APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6)2023. THE PATIENT HAS SUFFERED SEVERE PAIN AND LOSS OF MOBILITY. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Pain

  MAUDE report 17343703 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL LEFT TKA, A 64 YO MALE PATIENT HAD A REVISION DUE TO THE POLY DEVICE RECALL; NO OTHER REASON REPORTED. DEVICE WAS RECEIVED (B)(6) 2022. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 16092480 ↗
• InjuryDec 27, 2022Detachment of Device or Device Component; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, AFTER MULTIPLE ATTEMPTS.

  Patient problems: Implant Pain; Pain

  MAUDE report 16052481 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR INDEX SURGERY ON (B)(6) 2018. PATIENT'S KNEE WAS REVISED. HE WAS DOING THE REVISION BECAUSE THE PATIENTS¿ KNEE WAS TIGHT IN FLEXION. THE SURGEON OPENED THE JOINT IN STANDARD FASHION. HE DECIDED TO LOWER THE POLY TO A SIZE NINE AND CHANGED THE PATELLA TO A 35 MM. THE PATIENT HAD BETTER FLEXION AFTER THIS. THE SURGEON IMPLANTED THE FINAL IMPLANTS AND CLOSED THE KNEE IN STANDARD FASHION. THE PATIENT LEFT THE OR IN STABLE CONDITION.

  Patient problems: Loss of Range of Motion; No Information

  MAUDE report 9239969 ↗

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-