Truliant 02-022-47-4013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862306494), received between Nov 4, 2019 and May 6, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2017. THE PATIENT WAS REVISED DUE TO INSTABILITY ON (B)(6) 2024 AND ALL IMPLANTS WERE REMOVED AND REPLACED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19256361 ↗
• InjuryOct 5, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST OP DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arthrofibrosis; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 15546476 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 66 Y/O MALE PATIENT WAS INITIALLY IMPLANTED WITH A RIGHT TKA ON (B)(6)2017. THE PATIENT BEGAN EXPERIENCING SWELLING, PAIN AND REDNESS AND PRESENTED TO THE CLINIC ON (B)(6) 2019 AND WAS PRESCRIBED KEFLEX. ON (B)(6) 2019, THE RIGHT KNEE WAS ASPIRATED AND CULTURED. LABS FOUND INFECTION AND ON (B)(6)2019, THE PATIENT HAD THE TIBIAL INSERT REPLACED, ALONG WITH EXCISIONAL DEBRIDEMENT AND IRRIGATION AND DRAINAGE. THIS CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THE CASE REPORT FORM INDICATES THIS EVENT WAS RESOLVED WITH REVISION SURGERY ON (B)(6) 2019. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bacterial Infection; Erythema; Joint Swelling; Pain; Unspecified Infection

  MAUDE report 9276370 ↗