Truliant 02-022-51-4511Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862307828), received between May 9, 2023 and Aug 20, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  LEGAL CASE - USA (MDL: 3044) (NGG) (MMH) RELATED CASE: (B)(4). IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, SUFFERED FROM PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE IMPLANTATION OF THE EXACTECH DEVICE AND SUBSEQUENT REVISIONS HAVE CAUSED PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES, AND HE WILL SUSTAIN FUTURE DAMAGES INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. ACCORDINGLY, PLAINTIFF IS SEEKING COMPENSATORY AND SPECIAL DAMAGES, INCLUDING ATTORNEYS' FEES AND COSTS, AND ALL OTHER AVAILABLE REMEDIES UNDER THE LAW. . NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20000950 ↗
• InjuryJun 25, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 8 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. PLAINTIFF SUFFERED FROM PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE IMPLANTATION OF THE EXACTECH DEVICE AND SUBSEQUENT REVISIONS HAVE CAUSED PERSONAL INJURIES, SEVERE PAIN AND SUFFERING, MENTAL ANGUISH, EMOTIONAL DISTRESS, FEAR, LOSS OF ENJOYMENT OF LIFE, MEDICAL EXPENSES, AND FINANCIAL LOSSES, AND HE WILL SUSTAIN FUTURE DAMAGES INCLUDING BUT NOT LIMITED TO COST OF MEDICAL CARE, REHABILITATION, MENTAL AND EMOTIONAL DISTRESS, AND PAIN AND SUFFERING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Emotional Changes; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19607789 ↗
• InjuryMay 7, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 35 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE FUTURE REVISION SURGERY FOR POLYETHYLENE WEAR. THE PATIENT IS CURRENTLY CLAIMING THE FOLLOWING COMPLICATION/INJURIES AS A RESULT OF THEIR IMPLANT: PAIN, INSTABILITY, SWELLING, AND NUMBNESS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Joint Laxity; Numbness; Pain; Swelling/ Edema

  MAUDE report 19258384 ↗
• InjuryMay 9, 2023Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO A WORN POLY AND POSSIBLE POLY DEBRIS IN THE WOUND OVER TIME. THIS WAS A POLY EXCHANGE FOR A POSSIBLE RECALLED POLY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16900056 ↗

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-