Truliant 02-022-49-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862307194), received between Apr 26, 2023 and Apr 26, 2023 — 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.

• InjuryApr 26, 2023Naturally Worn; Naturally Worn

  PER A REPORT FROM THE LEGAL DEPARTMENT A 69 Y/O FEMALE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2019. APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2023. REVISION OP REPORT ((B)(6) 2023). POSTOPERATIVE DIAGNOSIS: RIGHT KNEE ARTHROPLASTY FAILURE. PATIENT HAD INCREASED PAIN AND A SMALL EFFUSION. ESR AND CRP WERE NEGATIVE. CT SCAN RULED OUT LYSIS OR EVIDENCE OF LOOSENING. DURING THE REVISION A SMALL EFFUSION WITHOUT ANY METALOSIS OR PURULENCE PRESENT. A SYNOVECTOMY OF THE SUPRAPATELLAR POUCH, MEDIAL AND LATERAL GUTTERS AND INTERCONDYLAR NOTCH AND THEN EXPOSED THE POLYETHYLENE AND WAS ABLE TO REMOVE THE OSTEOTOME AND MALLET. THERE WAS SOME VERY SUPERFICIAL PITTING OF THE POLYETHYLENE. THE PATIENT WAS AWOKEN AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO COMPLICATIONS OCCURRED THROUGHOUT THE CASE.

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 16816875 ↗