Truliant 02-022-47-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862306487), received between Aug 8, 2023 and Apr 23, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Mechanical Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE SURGEON HAD A FEMALE PATIENT THAT CAME IN WITH A SMALL NON DISPLACED DISTAL FEMUR FRACTURE ON THE MEDIAL SIDE OF THE FEMUR THAT HAD A TRULIANT TOTAL RIGHT KNEE IMPLANTED ON (B)(6) 2021. THE SURGEON SAID THE PATIENT KNEW SHE WAS PART OF THE POLY RECALL AND STATED SHE FELL BECAUSE HER KNEE WAS UNSTABLE "BECAUSE OF THE RECALL". DURING SURGERY A COMPETITOR'S RETROGRADE NAIL WAS USED TO REPAIR THE FRACTURE. THE TOTAL KNEE COMPONENTS WERE WILL FIXED AND THE POLY INSERT WAS REMOVED. THERE WERE NO SIGNS OF WEAR ON THE POLY AND IT HAD NO NOTICEABLE OXIDATION OR DELAMINATION. A NEW ACTIVIT-E SZ 4, 12MM POLY WAS INSERTED AND IMPLANTED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES OF THE LINER WERE TAKEN. PHOTOS/X-RAYS RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO POLY WAS KEPT AFTER CASE CONCLUDED.

  Patient problems: Anxiety; Bone Fracture(s); Failure of Implant; Implant Pain; Joint Laxity; Loss of Range of Motion

  MAUDE report 19169045 ↗
• InjuryAug 8, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS MALE PATIENT'S KNEE WAS REVISED DUE TO THE RECALL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. NO X-RAYS OR PHOTOS AVAILABLE. DEVICE IS NOT RETURNING - HOSPITAL KEPT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17478846 ↗