Truliant 02-022-51-2517Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862307613), received between Nov 3, 2022 and Nov 3, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE YEARS POST PATIENT¿S FIRST RIGHT SIDE TKA REVISION, THE 60 Y/O FEMALE PATIENT PRESENTED BACK TO SURGEON¿S OFFICE WITH COMPLAINTS OF INSTABILITY. AFTER EXAMINATION THE SURGEON SCHEDULED THE PATIENT FOR A REVISION RIGHT TKA POSSIBLE POLY EXCHANGE. THIS IS THE SECOND POLY EXCHANGE FOR THIS PATIENT. ON 10-OCT-2022 THE PATIENT UNDERWENT REVISION SURGERY. THE SURGEON OPENED THE KNEE JOINT AND PERFORMED A SYNOVECTOMY. HE REMOVED SCAR TISSUE FROM AROUND THE PATELLA AND AROUND THE KNEE IMPLANT. HE WENT THROUGH A RANGE OF MOTION (ROM) TO SHOW THE INSTABILITY IN THE KNEE, HE THEN USED A THIN CURVED OSTEOTOME TO REMOVE THE POLY IMPLANT. UPON PHYSICAL EXAMINATION OF THE POLY, IT DID NOT APPEAR TO HAVE PHYSICAL ISSUES OR CHARACTERISTICS OUT OF NORMAL. THE SURGEON THEN BEGAN TO TRIAL THE CRC-STYLE POLY IN A SIZE 19MM. HE WAS SATISFIED WITH THE STABILITY OF THE 19MM. THE SURGEON DID NOT HAVE ANY THICKER POLY OPTIONS FROM EXACTECH TO GO UP TO OTHER THAN THE 19MM, IF THE SURGEON NEEDED A THICKER OR A LARGER IMPLANT, HE WOULD NEED TO PERFORM A FULL REVISION ON THE IMPLANTS. THE BACK OF THE KNEE WAS CLEANED OUT AND THE KNEE JOINT WAS IRRIGATED. THE NEW 19MM CRC POLY WA

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15721312 ↗