Truliant 02-022-44-1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862304865), received between Mar 9, 2022 and Mar 9, 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.

• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWO YEARS POST INITIAL RIGHT SIDE TKA, THIS FEMALE PATIENT WAS HAVING RIGHT KNEE PATELLA DISLOCATIONS. THE POLY INSERT WAS REMOVED AND THE FEMORAL PROSTHESIS WAS REMOVED. THE PATIENT RECEIVED A SIZE 1 RIGHT LOGIC CC FEMUR,12X80 CEMENTED STEM, AND A 13MM POLY INSERT. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO THE HOSPITAL SENT OFF IMPLANTS WITH TISSUE.

  Patient problems: Joint Dislocation

  MAUDE report 13709303 ↗