Truliant 02-022-44-4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862305282), received between Sep 24, 2022 and Apr 9, 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.

• InjuryApr 9, 2024Mechanical Problem; Naturally Worn; Mechanical Problem; Naturally Worn

  IT IS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021, WITH NO REVISION SURGERY REPORTED. THERE IS NO DEVICE INFORMATION PROVIDED. NO RADIOGRAPHIC IMAGES OF THE DEVICE ARE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Loss of Range of Motion; Pain

  MAUDE report 19069013 ↗
• InjuryApr 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 5 YEARS AND 4 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Osteolysis; Synovitis

  MAUDE report 19010254 ↗
• InjuryNov 10, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 60 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 2 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH PAIN, STIFFNESS AND SYNOVITIS. HE WAS REVISED FROM AN 11MM PSC INSERT TO A 9MM CRC WITH GOOD ROM AND STABILITY. THE INSERT HAD NO VISUAL DAMAGE EXCEPT FOR WHAT INCURRED FROM USING THE OSTEOTOME FOR REMOVAL. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Ambulation or Postural Difficulties; Implant Pain; Pain

  MAUDE report 15777477 ↗
• InjurySep 28, 2022Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2011. THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO UNKNOWN REASONS. NO OTHER INFORMATION REPORTED.

  Patient problems: Failure of Implant; Joint effusion; Synovitis

  MAUDE report 15500626 ↗
• InjurySep 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD A BILATERAL TKA ON (B)(6) 2013. THE PATIENT'S LEFT KNEE WAS REVISED ON (B)(6) 2022 FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY AND/OR COMPONENT LOOSENING. THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS KNEES WHICH LIMITED AND CONTINUES TO LIMIT HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE.

  Patient problems: Failure of Implant

  MAUDE report 15476574 ↗