Truliant 02-022-35-2512Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862304193), received between Jan 4, 2023 and Dec 9, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K171045); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1 YEAR AND 3 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT'S POLY WAS REMOVED AND REPLACED TO ADDRESS PATIENT KNEE TIGHTNESS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 20879199 ↗
• InjuryApr 17, 2023Unstable; Appropriate Device Problem Term/Code Not Available; Lack of Effect; Unstable; Appropriate Device Problem Term/Code Not Available; Lack of Effect

  STUDY: EXACTECH TRULIANT KNEE CLINICAL STUDY; SUBJECT: (B)(6). IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 43 YO FEMALE PATIENT UNDERWENT I&D TOTAL KNEE ARTHROPLASTY WITH TIBIAL INSERT EXCHANGE & COMPLETE SYNOVECTOMY OF THE RIGHT KNEE. DUE TO WORSENING PAIN, DETERIORATING RANGE OF MOTION, PROGRESSIVE DEFORMITY, AND SIGNIFICANT INTERFERENCE WITH FUNCTION THE ONLY OPTION FOR PAIN CONTROL AND FUNCTIONAL RESTORATION IS TOTAL KNEE REPLACEMENT REVISION DUE TO LAXITY DEVELOPED POST-TKA AND DATING BACK TO PREVIOUS KNEE PROCEDURE. THE DATE OF EVENT ONSET IS (B)(6) 2018. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON 10-08-2018.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 16755815 ↗
• InjuryApr 17, 2023Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: EXACTECH TRULIANT KNEE CLINICAL STUDY ;SUBJECT: (B)(6) . IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 43 YO FEMALE PATIENT WAS EVALUATED IN THE EMERGENCY DEPARTMENT BY THE ORTHOPEDIC SURGERY SERVICE DUE TO 1-DAY OF INCREASING LEFT KNEE PAIN S/P LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017. THE PATIENT PRESENTS TO THE EMERGENCY DEPARTMENT WITH A FEVER OF 102.7, TACHYCARDIC, A NEW WHITE COUNT OF 11.3, AND A CRP OF 114. THE PATIENT NOTED A FEVER TO TMAX 102 AT HOME AND INCREASING LEFT KNEE PAIN WITH CHILLS. PATIENT WAS ADMITTED TO THE ORTHOPEDIC SURGERY SERVICE FOR FURTHER MONITORING/INFECTIOUS WORKUP AND JOINT ASPIRATION. THE DATE OF EVENT ONSET IT (B)(6) 2017. THE PATIENT¿S STANDARD REVERSE SHOULDER SYSTEM WAS REVISED TO HEMIARTHROPLASTY. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Chills; Fever; Implant Pain; Medical device site infection; Unspecified Infection

  MAUDE report 16753298 ↗
• InjuryJan 4, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT PS TKA, THIS 62 Y/O FEMALE PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. THE PATIENT UNDERWENT THE POLY SWAP WHERE THE SURGEON REMOVED THE PRIMARY POLY IMPLANT, TRIALED WITH A THINNER 9MM OPTION, AND RE-IMPLANTED A 9MM PS POLY FOR SIZE 2.5 FEMUR. KNEE ROM WAS ASSESSED AND THE SURGEON WAS SATISFIED WITH THE STABILITY. THE KNEE WAS IRRIGATED WELL AND CLOSED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 16099382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171045. One submission often covers many models, so check the product and lot details in each record.

• Z-0585-2024 · Nov 21, 2023 · Open, Classified
  Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-