Truliant 02-022-47-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862306395), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED A 76 YO FEMALE PATIENT, INITIAL KNEE IMPLANTED, UNKNOWN DATE AND SIDE, UNDERWENT A REVISION PROCEDURE, DATE OF EVENT UNKNOWN. THE REPORTED INFORMATION INDICATED THE PATIENT¿S POLY WAS SWAPPED DUE TO THE RECALL, HOWEVER THE SERIAL NUMBER PROVIDED WAS NOT CONFIRMED TO BE A RECALL DEVICE. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE HOSPITAL KEPT THE DEVICE. NO X-RAYS OR DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 17479905 ↗