Truliant 02-022-44-3017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862305145), received between May 9, 2023 and Oct 15, 2024 — classified as 2 injuries.

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

• InjuryOct 15, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4) ), (B)(4) LK, (B)(4), RK REV 2, (B)(4), RK REV 3 IS ASSOCIATED WITH THIS CASE. IT IS REPORTED VIA LEGAL DOCUMENTATION THE PLAINTIFF UNDERWENT RIGHT KNEE REPLACEMENT ON (B)(6) 2019 AND REVISOIN #1, RIGHT KNEE ON (B)(6) 2023. (SHORT FORM COMPLAINT ATTACHED). IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 45 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 20452391 ↗
• InjuryMay 9, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2020. APPROXIMATELY 2 YEARS AND 7 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022 DUE TO INSTABILITY, PAIN AND LACK OF MOBILITY. THE CLINICAL FINDINGS AND DIAGNOSES AS A RESULT OF THE REVISION SURGERY ARE CONSISTENT WITH THE DEFECTS OF THE EXACTECH KNEE SYSTEM. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Pain; Scar Tissue; Synovitis

  MAUDE report 16895029 ↗