Truliant 02-022-44-2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862304933), received between Mar 31, 2023 and Jun 11, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. INITIAL SURGERY AND REVISION 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: Insufficient Information

  MAUDE report 19509188 ↗
• InjuryFeb 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 18778723 ↗
• InjuryMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL BRIEF THAT ON (B)(6) 2020, A PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY IN WHICH SHE WAS IMPLANTED WITH EXACTECH, LEFT KNEE REVISION, SERIAL #(B)(4). IT IS STATED THAT ¿THE LEFT KNEE REVISION IMPLANT AGAIN FAILED¿; SHE REQUIRED AN ADDITIONAL REVISION SURGERY AND WILL BE REQUIRED TO UNDERGO FURTHER REVISION SURGERY. 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: Failure of Implant

  MAUDE report 16657264 ↗