Truliant 02-022-44-5011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862305466), received between Nov 1, 2021 and Aug 14, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 20 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, SWELLING, DISCOMFORT, INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 19981410 ↗
• InjuryJun 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN TRULIANT DEVICE ON THE LEFT KNEE, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19609917 ↗
• InjuryJun 3, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 47 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint effusion; Medical device site infection; Pain

  MAUDE report 19454704 ↗
• InjuryMay 3, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT ON (B)(6)2020. HE THEN HAD RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 2 YEARS 1 MONTH AFTER THEIR INITIAL PROCEDURE. POSTOPERATIVE DIAGNOSIS: POLYETHYLENE PARTICULATE DEBRIS-INDUCED SYNOVITIS, RIGHT TOTAL KNEE ARTHROPLASTY IN THE EXACTECH RECALL GROUP. THERE WAS FOUND TO BE AN EFFUSION WITH PSEUDOMEMBRANE FORMATION AND SIGNS OF CHRONIC SYNOVIAL INFLAMMATION. ALL COMPONENTS WERE WELL-FIXED. THERE WAS EARLY WEAR ON THE POSTERIOR PART OF THE POLYETHYLENE COMPONENT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Implant Pain; Joint effusion; Muscle Weakness/Atrophy; Synovitis

  MAUDE report 16863942 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A (B)(6) Y/O MALE PATIENT WHO IS 27 MONTHS POSTOP A RTKA RETURNED WITH PAIN. THE SURGEON DECIDED TO REPLACE THE POLY AND DEBRIDE THE JOINT. A TRULIANT 11MM PSC WAS REPLACED WITH A 13MM PSC. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION DUE TO HOSPITAL RETAINS ALL RETRIEVALS.

  Patient problems: Failure of Implant

  MAUDE report 12732873 ↗