Truliant 02-022-51-1511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862307460), received between May 4, 2022 and May 4, 2022 — classified as 1 injury.

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.

• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT'S SURGEON BOOKED A REVISION TKA WITH PATELLECTOMY. THE PATIENT HAD A FALL ON THEIR TOTAL KNEE AND POST THE FALL THE PATIENT WAS HAVING PAIN AND INSTABILITY. THE POLY IMPLANT THAT WAS IN THE PATIENT AND REMOVED DURING THE REVISION SURGERY WAS AFFECTED BY THE EXACTECH MANUFACTURER KNEE POLY RECALL. THE SURGEON WENT FROM WHAT WAS IN AN 11 MM CRC TO TRAILING AND IMPLANTING A 15 MM CRC POLY. THE SURGEON REMOVED BONE FROM THE PATELLA AND CLOSED THE KNEE. THE PATIENT LEFT THE OR STABLE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS & X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THE DEVICES WERE DISCARDED OR LOST IN TRANSIT FROM THE SX ROOM TO DECONTAMINATION AND SPD.

  Patient problems: Pain

  MAUDE report 14279475 ↗