Truliant 02-022-51-3511Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862307705), received between Sep 2, 2022 and Aug 15, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Unstable; Unstable

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR POST-OP, THE PATIENT EXPERIENCED PAIN AND INSTABILITY. IT WAS NOTED THE SURGEON ATTEMPTED A TRIAL OF BRACING; HOWEVER, APPROXIMATELY ONE (1) YEAR LATER, THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE TIBIAL POLYETHYLENE COMPONENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22816833 ↗
• InjurySep 12, 2024Naturally Worn; Naturally Worn

  LEGAL CASE ¿ USA (MASTER CASE NO. (B)(4)) IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 32 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, SWELLING, INSTABILITY, AND OSTEOLYSIS. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Implant Pain; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 20199722 ↗
• InjuryAug 6, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 20 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, DEGENERATIVE JOINT DISEASE, PAIN, DISCOMFORT, SWELLING, MOTION RESTRICTION, DIFFICULTY WITH AMBULATION AND PERFORMING SIMPLE ACTIVITIES OF DAILY LIVING, FINANCIAL HARDSHIP. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain; Swelling/ Edema

  MAUDE report 19918980 ↗
• InjuryJun 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN TRULIANT DEVICE ON THE RIGHT KNEE, WITH NO REVISION SURGERY REPORTED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Implant Pain; Insufficient Information; Swelling/ Edema

  MAUDE report 19534101 ↗
• InjuryJun 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 32 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19513117 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TWENTY-ONE DAYS POST INITIAL RIGHT TKA, THE 54 Y/O FEMALE PATIENT HAD THE TIBIAL INSERT EXCHANGED FOR A NEW ONE OF THE SAME SIZE DURING A WASH OUT PROCEDURE DUE TO INFECTION. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN X-RAYS OR IMAGES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO BEING AGAINST HOSPITAL POLICY.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 17400517 ↗
• InjuryJun 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT'S LEFT KNEE WAS REVISED. PATIENT HAD A POLY SWAP. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION REPORTED. NO X-RAYS OR PHOTOS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT INFORMATION PROVIDED. PRODUCT NOT RETURNING REASON NOT REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17118633 ↗
• InjurySep 2, 2022Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL TKA ON (B)(6) 2020. THE PATIENT SHOWED UP TO THE CLINIC WITH PAIN AND SYNOVITIS. THE PATIENT WAS REVISED ON (B)(6) 2022. LAXITY WAS NOTED. THERE WAS SOME PITTING AND SURFACE CHANGES NOTED ON THE INSERT. THE PATIENT WAS STABLE AND HAD GOOD ROM. A NEW INSERT WAS IMPLANTED. THE PATIENT LEFT IN STABLE CONDITION.

  Patient problems: Failure of Implant; Joint Laxity; Pain; Synovitis

  MAUDE report 15349005 ↗