Truliant 02-022-35-4012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862304469), received between Jan 16, 2024 and Apr 8, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Unstable

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD A RTKA, UNDERWENT A REVISION PROCEDURE DUE TO INSTABILITY. THE 12MM POLY WAS FOR A 15MM INSERT. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. NO IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation

  MAUDE report 24822909 ↗
• InjuryJun 10, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 68 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 19503963 ↗
• InjuryMay 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 63 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS 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; Pain

  MAUDE report 19329878 ↗
• InjuryJan 25, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT WAS CONVERTED FROM A COMPETITOR SYSTEM TO A RIGHT SIDE EXACTECH TKA ON (B)(6) 2018. THE PATIENT UNDERWENT A POLY SWAP IN 2020; DATE UNKNOWN AND REASON UNKNOWN. THERE IS NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Pain

  MAUDE report 18585186 ↗
• InjuryJan 16, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT KNEE REVISION, REASON NOT PROVIDED. INITIAL IMPLANT (B)(6) 2018 AND A TOTAL KNEE REVISION ON (B)(6) 2023. TOTAL REVISION APPROXIMATELY 4 YEARS 10 MONTHS AFTER INITIAL IMPLANT. FOR ALL OTHER IMPLANTS AND THE PATIENT WAS REVISED TO EXACTECH DEVICES. REPORTED EVENT IS NOT RELATED TO BREAKAGE OF DEVICE AND DID NOT LEAD TO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE IS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. THERE IS NO INFORMATION ABOUT THE REVISION SURGICAL PROCEDURE PROVIDED. THERE IS NO OTHER INFORMATION PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthralgia; Discomfort; Insufficient Information; Muscle Weakness/Atrophy; Pain

  MAUDE report 18518328 ↗

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-