Truliant 02-022-35-6009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862304704), received between Oct 10, 2023 and Mar 22, 2024 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020, AND THEN EXPERIENCED REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 2 YEARS AND 8 MONTHS AFTER INITIAL IMPLANT. NO IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Implant Pain; Inflammation; Joint Laxity; Joint effusion; Pain; Scar Tissue

  MAUDE report 18957824 ↗
• InjuryJan 27, 2024Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE PATIENT COMPLAINED OF PAIN AND HAD A RECALLED POLY AND WAS REVISED ON (B)(6) 2024. THE INSERT WAS REPLACED. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO REPORTED RELEVANT MEDICAL HISTORY OR COMORBIDITIES.

  Patient problems: Failure of Implant; Granuloma; Joint effusion; Pain; Scar Tissue; Synovitis

  MAUDE report 18592805 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EXACTECH TRULIANT KNEE CLINICAL STUDY, APPROXIMATELY 1 YEAR POST OP INITIAL LEFT TKA, THIS 72 Y/O MALE PATIENT WAS EXPERIENCING KNEE PATELLAR CLUNK. PATIENT WAS HAVING PAIN THAT HAS BEEN NON-RESPONSIVE TO CONSERVATIVE MEASURES. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES AND DEFINITELY PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 18419634 ↗
• MalfunctionOct 11, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THIS PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019. THERE IS NO REPORTED REVISION AT THIS TIME. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17912830 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6)2021. APPROXIMATELY 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION ON (B)(6) 2022. PATIENT WAS REVISED TO COMPETITOR¿S DEVICES. ON (B)(6) 2022, REVISION OPERATIVE REPORT- POSTOPERATIVE DIAGNOSIS: 1. FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO ARTHROFIBROSIS WITH SIGNIFICANT FLEXION CONTRACTURE. 2. CHRONIC QUADRICEPS TENDON RUPTURE. INDICATIONS: 66 YO MALE HAD RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021. HE HAD A FALL POSTOPERATIVELY ON (B)(6) 2021, SUSTAINING A RIGHT PATELLAR FRACTURE WITH DISRUPTION OF HIS QUADRICEPS TENDON. HE UNDERWENT QUADRICEPS TENDON REPAIR AND ORIF OF THE RIGHT PATELLA ON (B)(6) 2021. HE WAS INSTRUCTED TO REMAIN IN A KNEE BRACE LOCKED IN EXTENSION; HOWEVER, THE BRACE SLID DOWN HIS LEG AND BENT THE KNEE WELL PAST 90 DEGREES. HE ULTIMATELY FAILED THE FRACTURE FIXATION AS WELL AS THE QUADRICEPS REPAIR. HE CONTINUED TO HAVE A VERY LIMITED MOBILITY AND SPENT MOST TIME SITTING. HE SUBSEQUENTLY DEVELOPED A SIGNIFICANT FLEXION CONTRACTURE OF HIS RIGHT KNEE WITH THE INABILITY TO AMBULATE OR STAND, GIVEN EXTENSOR MECHANISM DISRUPTION. INFECTION WOR

  Patient problems: Adhesion(s)

  MAUDE report 17906056 ↗