Truliant 02-022-51-3510Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862312617), received between Sep 20, 2022 and May 7, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT UNDERWENT A POLY SWAP SECONDARY TO ARTHROTOMY FAILURE. 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 ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21980566 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA CLINICAL STUDY APPROXIMATELY 1 MONTH AFTER A TOTAL KNEE REPLACEMENT, PATIENT UNDERWENT REVISION PROCEDURE TO ADDRESS, KNEE PAIN, SWELLING, POPPING, INABILITY TO FULLY EXTEND KNEE, AND RUPTURE OF LEFT PATELLAR TENDON. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Inflammation; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Rupture

  MAUDE report 19629243 ↗
• InjuryMar 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2022 APPROXIMATELY 1 YEAR AND 1 MONTH AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Emotional Changes; Pain

  MAUDE report 18863420 ↗
• InjuryNov 30, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD A POLY SWAP DUE TO LEFT KNEE INSTABILITY. PATIENT WAS REVISED TO A TRULIANT CRC 3 5X15 MM. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 18240337 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT (B)(6) 2020. SHE HAD THE RIGHT KNEE REVISED ON (B)(6) 2023, APPROXIMATELY 2 YEARS 4 MONTHS AFTER THEIR INITIAL REPLACEMENT. SURGEON NOTED THAT UPON EXAMINATION OF THE REMOVED POLY, THERE WAS "ABSOLUTELY NO WEAR AT ALL THAT I COULD IDENTIFY FROM A MACROSCOPIC PERSPECTIVE. THERE WAS NO BACKSIDE WEAR AND NO WEAR AT ALL, NO DEEP DELAMINATION NOTED." THE INTERFACE OF THE PATELLA, THE FEMUR AND THE TIBIA WERE EVALUATED AND FOUND TO BE "PRISTINE." 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.

  Patient problems: Insufficient Information; Pain

  MAUDE report 16878565 ↗
• InjurySep 20, 2022Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 37 Y/O MALE PATIENT WAS REVISED DUE TO THE BONE NEVER GREW INTO THE POROUS COMPONENTS. THE POROUS COMPONENTS WERE REVISED TO CEMENTED COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING, HOSPITAL POLICY.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 15454650 ↗

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-