Truliant 02-022-51-4510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862312679), received between Nov 7, 2022 and Jul 20, 2023 — classified as 4 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.

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.

• InjuryJul 20, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 2.5 YEARS POST INITIAL LEFT TKA, THE 59 Y/O PATIENT HAD REVISION DUE TO PAIN. THERE WAS NOT MUCH WEAR REPORTED UPON VISUAL EXAMINATION. THERE WAS NO ISSUES WITH POLY EXCHANGE. THE EXPLANTS ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Pain

  MAUDE report 17362347 ↗
• InjuryMay 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED TO THE SURGEON FOR AN EXCHANGE DUE TO THE DEVICE RECALL. THERE IS NO MENTION OF ANY OTHER CONDITIONS PRE-REVISION PROCEDURE. THE POLYETHYLENE COMPONENT WAS REMOVED AND "IT WAS INTACT". THERE ARE NO OTHER INTRAOPERATIVE CONDITIONS MENTIONED. THE PATIENT WAS REVISED TO AN EXACTECH DEVICE. STERILE DRESSING WAS APPLIED AND THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16844026 ↗
• InjuryDec 6, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED A MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 3 MONTHS POST THE INITIAL PROCEDURE DUE TO PAINT AND SYNOVITIS. SOME MODERATE WEAR WAS NOTED PER SURGEON. THE KNEE WAS A LITTLE TIGHT IN FLEXION, SO RELEASES WERE PERFORMED AND A THINNER SIZE 9MM INSERT WAS USED WITH GOOD ROM AND STABILITY. THE PATIENT LEFT IN STABLE CONDITION. EXPLANT NOT AVAILABLE. NO FURTHER INFORMATION.

  Patient problems: Implant Pain; Pain; Synovitis

  MAUDE report 15923022 ↗
• InjuryNov 7, 2022Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL TSA, THIS MALE PATIENT WAS REVISED DUE TO WEAR ON POLY AND SYNOVITIS. PATIENT WAS COMPLAINING OF PAIN. PATIENT LAST KNOWN TO BE IN STABLE CONDITION. EXPLANTS UNAVAILABLE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain; Synovitis

  MAUDE report 15742757 ↗

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-