Truliant 02-022-44-4017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862305336), received between Nov 4, 2020 and Aug 22, 2022 — classified as 2 injuries.

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.

• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT HAD A REVISION DUE TO THE CAPSULE RELEASING, CAUSING PAIN AND SWELLING IN THE RIGHT TKA SITE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 15272224 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 14 MONTHS POSTOP THE INITIAL LEFT TKA, THIS MALE PATIENT HAD KNEE INSTABILITY AND REQUIRED A REVISION. THE SURGEON USED A 8MM LOGIC PTS SPACER WITH A 15MM PSC INSERT, WHICH WAS A THICKER POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL NOT RETURN AS THE POLY WAS SENT OFF WITH TISSUE.

  Patient problems: Failure of Implant

  MAUDE report 10786729 ↗