Truliant 02-022-51-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862307767), received between Nov 25, 2023 and May 7, 2026 — classified as 6 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.

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, 2026Naturally Worn

  AS REPORTED BY LEGAL NOTIFICATION, APPROXIMATELY 1 YEAR AND 8 MONTHS POST THE INITIAL TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED. BECAUSE THE PATIENT HAS FILED A LEGAL CLAIM, IT APPEARS THAT THEY ARE ALLEGING PROSTHESIS WEAR OF THEIR EXACTECH DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25111874 ↗
• InjuryJan 15, 2025Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2021. IT HAS NOT BEEN EXPLANTED. 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

  MAUDE report 21157501 ↗
• InjuryDec 2, 2024Adverse 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 WAS REVISED DUE TO PAIN. THE PATELLA WAS REMOVED AND REPLACED WITH A COMPETITOR'S PATELLA. A NEW 12MM CRC VIT E INSERT WAS ALSO PLACED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Pain

  MAUDE report 20821751 ↗
• InjuryNov 15, 2024Naturally Worn; Naturally Worn

  AS REPORTED, A YEAR AFTER THE INITIAL SURGERY, THE PATIENT UNDERWENT A REVISION OF THE POLY DUE TO PITTING. NO FURTHER DETAILS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20699028 ↗
• InjuryJul 18, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 44 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PERMANENT AND DEBILITATING INJURIES AND DAMAGES, SIGNIFICANT PAIN AND DISCOMFORT, GAIT IMPAIRMENT, POOR BALANCE, DIFFICULTY WALKING; COMPONENT PART LOOSENING, SOFT TISSUE DAMAGE, BONE LOSS. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 19778313 ↗
• InjuryNov 25, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, FOLLOWING A REVISION SURGERY FOR INSTABILITY AND PAIN ON (B)(6) 2023 (CASE (B)(4)), THE PATIENT REPORTED RIGHT KNEE PAIN AND INSTABILITY. THE SURGEON WILL DISCUSS CONTINUED OPTIONS FOR THE RIGHT KNEE WITH THE PATIENT.

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

  MAUDE report 18207664 ↗