Truliant 02-022-35-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862304278), received between Dec 1, 2021 and Jan 16, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY FIVE YEARS POST INITIAL RIGHT TKA, THE 67 Y/O FEMALE PATIENT WAS REVISE OF A SIZE 3 FEMUR AND A RECALL TIBIAL INSERT. PATIENT WAS REVISED TO A SIZE 3 CONSTRAINED FEMUR WITH A PS SIZE 15 MM TIBIAL INSERT AND A STEM EXTENSION. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS AND IMAGES RECEIVED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT CAME IN DUE TO THE TIBIAL INSERT RECALL. PATIENT HAD A REVISION DUE TO RECALL AND THE FEMUR WAS LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 21171660 ↗
• InjuryMar 25, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 2 YEARS AND 11 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Failure of Implant; Pain

  MAUDE report 18967122 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, A PATIENT HAD RIGHT KNEE REVISION SURGERY ON (B)(6)2020. THEY HAVE NOT YET UNDERGONE A 2ND REVISION. 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. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. 2022 CA (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 PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18088129 ↗
• InjuryJun 30, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD RIGHT KNEE REPLACEMENT (B)(6) 2020. THEY UNDERWENT RIGHT KNEE REVISION ON (B)(6) 2022, APPROXIMATELY 1 YEAR 11 MONTHS AFTER THEIR INITIAL PROCEDURE. (B)(6) 2022 OP REPORT STATES THAT THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID AND WELL-FIXED FEMORAL, TIBIAL, AND PATELLAR COMPONENTS. THERE WAS A MILD TO MODERATE AMOUNT OF VISIBLE POLYETHYLENE WEAR WITHIN THE TIBIAL POLYETHYLENE. THERE WAS ALSO EVIDENCE OF A MILD AMOUNT OF POLYETHYLENE DEBRIS WITHIN SYNOVIAL ENCAPSULATION. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. 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: Failure of Implant; Osteolysis; Pain

  MAUDE report 17240023 ↗
• InjuryApr 20, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED BY LEGAL NOTIFICATION, THE FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022; REASON NOT REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 16782171 ↗
• InjuryDec 5, 2022Naturally Worn; Naturally Worn

  AS REPORTED BY THE TRULIANT KNEE CLINICAL STUDY, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6)2020. THE PATIENT PRESENTED WITH POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. A POLY EXCHANGE AND POSSIBLE FEMORAL REVISION WERE INDICATED, BUT THE PATIENT DECLINED SURGICAL INTERVENTION AT THIS TIME. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND UNLIKELY RELATED TO PROCEDURE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15921593 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED, THIS MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE SURGEON PERFORMED A POLY SWAP ON A LOGIC CC KNEE. THE PATIENT WAS COMPLAINING OF PAIN. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15848567 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT, HAD AN INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2018, AND UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 11 MONTHS POST THE INITIAL IMPLANT PROCEDURE FOR MEDIAL KNEE PAIN. IT WAS NOTED THERE WAS SOME SYNOVITIS AND SCAR TISSUE MEDIAL. A THICKER INSERT WAS SELECTED AFTER TRIALING. THE ORIGINAL PS INSERT WAS 11MM. A 13MM WAS IMPLANTED WITH GOOD STABILITY AND RANGE OF MOTION. IT WAS STATED THAT THE POLY HAD NO VISUAL DAMAGE UPON REMOVAL. THE EXPLANTS NOT AVAILABLE TO THE SALES REP. THE PATIENT LEFT IN STABLE CONDITION. NO PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Implant Pain; Pain; Scar Tissue; Synovitis

  MAUDE report 15756270 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE LEGAL BRIEF, MALE PATIENT UNDERWENT BI-LATERAL KNEE REPLACEMENT ON OR ABOUT (B)(6) 2019. THE SURGEON USED TRULLIANT TIBIAL INSERTS FOR BOTH KNEE REPLACEMENTS. THESE PRODUCTS WERE MANUFACTURED BY EXACTECH INC. AND HAVE SINCE BEEN RECALLED BY EXACTECH. FOLLOWING THE INITIAL OPERATIONS, PATIENT HAS SUFFERED INJURIES AND DAMAGES DUE TO THE DEFECTIVE PRODUCTS, INCLUDING BUT NOT LIMITED TO, ADDITIONAL SURGICAL INTERVENTIONS.

  Patient problems: Failure of Implant

  MAUDE report 14781919 ↗
• MalfunctionDec 1, 2021Contamination; Contamination

  AS REPORTED, DURING SURGICAL USE OF THE TRULIANT TIB IMP PS INSERT SZ 3 11MM, A HAIR WAS NOTED IN THE DEVICE PACKAGE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED. PATIENT WAS NOT EFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908964 ↗