Truliant 02-022-51-2012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862312532), received between Aug 25, 2022 and Apr 17, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN WITH EFFUSION AND HAD A RIGHT KNEE ASPIRATION APPROXIMATELY EIGHT MONTHS POST-SURGERY. APPROXIMATELY FIVE YEARS AND NINE MONTHS LATER, THE PATIENT UNDERWENT A REVISION DUE TO FAILED POLYETHYLENE. DESPITE UNDERGOING THE REVISION SURGERY, THE PATIENT EXPERIENCES DAILY PAIN AND DISCOMFORT; GAIT IMPAIRMENT; POOR BALANCE; DIFFICULTY WALKING; COMPONENT PART LOOSENING; SOFT TISSUE DAMAGE; BONE LOSS; THAT LIMITS THEIR ACTIVITIES OF DAILY LIVING. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Discomfort; Osteolysis; Pain; Unspecified Tissue Injury

  MAUDE report 24912991 ↗
• InjuryAug 25, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  AS REPORTED, APPROXIMATELY 6.5 YEARS POST OP THE INITIAL TSA, THIS FEMALE PATIENT HAD A REVISION DUE TO A DIAGNOSIS OF "FAILED POLYETHYLENE, STATUS POST RIGHT KNEE ARTHROPLASTY".

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Aseptic loosening; Discomfort; Failure of Implant; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 15293598 ↗

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-