Truliant 02-022-35-4010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862304445), received between Sep 26, 2019 and Sep 13, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (7 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.

• InjurySep 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, INCREASING PAIN, REDNESS, SWELLING OF THE LEFT KNEE. INITIAL 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: Implant Pain; Pain; Swelling/ Edema

  MAUDE report 20211766 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT KNEE ARTHROPLASTY ON (B)(6) 2021, AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2024, APPROXIMATELY 3 YEARS AFTER INITIAL IMPLANT. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19372108 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 39 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SEVERE PAIN, DIFFICULTIES WITH MOBILITY, LIMITED PHYSICAL ACTIVITY AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Implant Pain

  MAUDE report 19330132 ↗
• InjuryMay 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 59 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19262126 ↗
• InjuryApr 16, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON : (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6)2023 APPROXIMATELY 5 YEARS AFTER INITIAL IMPLANT. OP REPORT ; POSTOPERATIVE DIAGNOSIS- PREMATURE POLY WEAR AND ASEPTIC FEMORAL LOOSENING. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain; Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 19113556 ↗
• InjuryMar 20, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019, WITH NO REVISION SURGERY REPORTED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 18938819 ↗
• InjuryAug 16, 2023Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 60 MONTHS AFTER A RIGHT KNEE TOTAL REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, CHRONIC PAIN AND SWELLING. POST OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, THE SURGEON OBSERVED POLYETHYLENE SYNOVITIS, SCAR TISSUE AND WEAR OF THE PATELLA BUTTON, WEAR OF THE POLYETHYLENE INSERT, LYSIS AROUND THE LATERAL CONDYLE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17555803 ↗
• MalfunctionSep 26, 2019Fitting Problem; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL LEFT TOTAL KNEE ARTHROPLASTY ON THIS MALE PATIENT WAS PERFORMED ON (B)(6) 2019 AT (B)(6) MEDICAL CENTER BY DR. (B)(6). DR. (B)(6) DECIDED TO DO THIS REVISION BECAUSE THE PATIENT WAS HAVING TROUBLE FLEXING HIS KNEE. DR. (B)(6) OPENED THE JOINT IN STANDARD FASHION. HE THEN TOOK OUT THE INSERT. HE CLEARED SCAR TISSUE AWAY BOTH MEDIALLY AND LATERALLY. HE THEN TOOK HIS SAW BLADE AND CUT OUT THE PATELLA. HE DID THIS BECAUSE WHEN HE MEASURED WITH A CALIPER IT WAS OVER 32MM IN THICKNESS. ONCE HE CUT IT OUT HE WAS ABLE TO RE-DRILL NEW HOLES FOR ANOTHER SMALLER PATELLA. HE ENDED UP IMPLANTING A 32 PATELLA WHICH FIT NICELY. HE THEN IMPLANTED A SIZE 9 INSERT WHICH ALLOWED THE PATIENT TO FLEX HIS KNEE TO MORE THAN 100 DEGREES. HE WAS PLEASED WITH THIS CONSTRUCT. HE THEN CLOSED THE KNEE IN STANDARD FASHION. THE PATIENT LEFT THE OR IN STABLE CONDITION. AND IS EXPECTED TO HAVE A GOOD OUTCOME. THERE WAS NO DELAY TO THE SURGERY. THE REP WAS PRESENT AT THE TIME OF THE SURGERY. THE HOSPITAL DID NOT RELEASE IMPLANTS TO BE RETURNED TO EXACTECH.

  Patient problems: No Code Available; No Information

  MAUDE report 9125916 ↗

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-