Truliant 02-022-44-3009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305077), received between Jul 19, 2022 and Jul 19, 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.

• InjuryJul 19, 2022Naturally Worn; Naturally Worn

  AS REPORTED, THIS 60 YEAR OLD, 107 KG., MALE PATIENT HAD A LEFT THA ON (B)(6) 2020. THE PATIENT WAS REVISED DUE TO POLY WEAR. THERE IS NO REPORTED BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 15051248 ↗