Truliant 02-022-44-4009Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862305268), received between Apr 20, 2022 and Jul 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Naturally Worn” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH A TRULIANT KNEE IN 2019. THE PATIENT HAS A RECALLED KNEE AND HAS BEEN EXPERIENCING PAIN SINCE IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Limb Pain; Pain

  MAUDE report 19728884 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 26 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PLAINTIFF UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. IT WAS REPORTED BY THE PLAINTIFF THAT AFTER THE IMPLANT SURGERY ON (B)(6) 2020, THE PLAINTIFF BEGAN HAVING PAIN WITH ANY WEIGHT BEARING ACTIVITIES WHICH PROGRESSIVELY WORSENED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19487587 ↗
• InjuryFeb 28, 2023Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA A LEGAL NOTIFICATION THAT A PATIENT, INITIAL BILATERAL KNEES IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON HIS LEFT KNEE ON (B)(6) 2019, IN WHICH HE WAS IMPLANTED WITH A RECALLED TRULIANT PSC TIBIAL INSERT. ON (B)(6) 2022, THE PLAINTIFF UNDERWENT A SECOND REVISION SURGERY ON HIS LEFT KNEE FOR ISSUES INCLUDING BUT NOT LIMITED TO POLYETHYLENE WEAR, BONE LOSS, OSTEOLYSIS, INSTABILITY, AND/OR COMPONENT LOOSENING. THE PLAINTIFF¿S REVISION SURGERIES WERE DUE TO ACCELERATED AND PREVENTABLE WEAR OF THE OPTETRAK AND TRULIANT POLYETHYLENE TIBIAL INSERTS. THE PLAINTIFF EXPERIENCES DAILY PAIN AND DISCOMFORT IN HIS LEFT KNEE WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. AS A DIRECT, PROXIMATE, AND LEGAL CONSEQUENCE OF THE DEFECTIVE NATURE OF THE DEVICE AS DESCRIBED HEREIN, THE PLAINTIFF HAS SUFFERED AND CONTINUES TO SUFFER PERMANENT AND DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, SIGNIFICANT PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. NO DEVICE R

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Insufficient Information; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16457504 ↗
• InjuryFeb 22, 2023Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unstable; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL DOCUMENTATION ON 5 OCT 2018, A PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT AND WAS IMPLANTED WITH A TRULIANT PSC POLYETHYLENE TIBIAL INSERT. ON (B)(6) 2022, APPROXIMATELY 4 YEARS, 2 MONTHS AFTER INITIAL IMPLANT, THE PATIENT UNDERWENT A REVISION SURGERY ON HIS RIGHT KNEE. 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. REVISION OP REPORT ON (B)(6) 2022. DIAGNOSIS: LOOSENING AND OSTEOLYSIS RIGHT KNEE THERE WAS A RELATIVELY LARGE OSTEOLYTIC LESION OF THE LATERAL TIBIAL PLATEAU AS WELL AS ON THE MEDIAL SIDE OF THE TIBIA. THE PATELLA WAS RESECTED AND REMOVED AND THE OSTEOLYSIS WAS CURETTED OUT OF THE PATELLA AND THEN ULTIMATELY AN ONLAY 35 PATELLA WAS ADDED. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Failure of Implant; Joint Laxity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16421140 ↗
• InjuryJul 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL TKA, THIS 63 Y/O MALE PATIENT WAS REVISED DUE PAIN IN LEFT KNEE. PATIENT RAN HIS KNEE INTO A DOOR FRAME. HE IS NOW HAVING PAIN. FEMORAL PATELLA, TIBIAL INSERT, TIBIAL TRAY WERE REVISED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 14935940 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY TEN MONTHS POST INITIAL RIGHT TKA, THIS (B)(6) MALE PATIENT WAS EXPERIENCING KNEE PAIN. SURGEON DECIDED TO REVISE THE FEMORAL AND TIBIAL COMPONENTS. THE PATIENT WAS REVISED TO EXACTECH KNEE REVISION COMPONENTS. 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 PHOTOS OR X-RAYS. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO IMPLANTS HAZARDOUS FOR BEING IN PATIENTS' BODY.

  Patient problems: Pain

  MAUDE report 14161605 ↗