Truliant 02-022-44-2511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862305008), received between Sep 9, 2022 and Sep 22, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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.

• InjurySep 22, 2023Unstable; Naturally Worn; Insufficient Device Problem Information; Unstable; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2020. APPROXIMATELY 3 YEARS AND 2 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. MASTER CASE NO. (B)(4). THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN ALACHUA COUNTY WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PAT

  Patient problems: Failure of Implant; Insufficient Information; Joint Laxity; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 17800349 ↗
• InjuryMay 22, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AND INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2019, AND THEN SHE HAD THE RIGHT KNEE REVISED ON (B)(6) 2023. THE REVISION SURGERY WAS APPROXIMATELY 2 YEARS, 7 MONTHS AFTER INITIAL IMPLANT. REVISION OPERATIVE REPORT OF (B)(6) 2023, FOR SUSPECTED POLYETHYLENE WEAR; RIGHT KNEE. THE PATIENT PRESENTED WITH PAINFUL KNEE. THEY WERE FOUND TO HAVE PROGRESSIVE POLYETHYLENE WEAR AS WELL AS INSTABILITY OF THE TOTAL KNEE. THE PATELLAR BUTTON WAS FOUND TO BE INTACT BUT WITH SOME SURFACE WEAR. THE POLY INSERT WAS REMOVED AND WAS NOTED TO BE INTACT WITH NOT GROSS DAMAGE. WITH REMOVAL OF THE FEMORAL COMPONENT THERE WAS NOTED ADIACENS BE AORI TYPE 1 BONE LOSS, NOT SEVERE. THE TIBIAL COMPONENT WAS GROSSLY INTACT, NOT LOOSE, IT WAS REMOVED WITH MINIMAL BONE LOSS. BONE LOSS OF THE TIBIAL METAPHYSIS WARRANTED THE USE OF A CONE. THE PATELLAR COMPONENT WAS REMOVED, AND THE PATELLA WAS RESURFACED. DRESSINGS WERE APPLIED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. PATIENT WAS ADMITTED (B)(6) 2023, AND WAS DISCHARGED (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 16981298 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT HAD A INITIAL RIGHT TKA ON (B)(6) 2022. THE PATIENT PRESENTED WITH AN INFECTED KNEE AND THE POLY WAS EXCHANGED DURING AN I&D PROCEDURE. A NEW POLY WAS IMPLANTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING AS IT IS AGAINST HOSPITAL POLICY.

  Patient problems: Bacterial Infection; Medical device site infection; Unspecified Infection

  MAUDE report 15390482 ↗