Truliant 02-022-35-4513Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862304568), received between May 2, 2023 and Nov 12, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2024Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 6 YEARS AND 2 MONTHS POST INITIAL LEFT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT WAS REVISED TO A COMPETITOR PROSTHESIS DUE TO COMPLAINTS OF PAIN, LOOSE FEMUR, AND RECALLED INSERT AND PATELLA. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 20668618 ↗
• InjuryJun 4, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 65 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19461061 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE 66 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT COMPLAINED OF PAIN AND UNDERWENT A POLY SWAP ON (B)(6) 2024. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19193894 ↗
• InjuryJun 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED VIA LEGAL DOCUMENTATION, THIS PATIENT HAD LEFT KNEE REPLACEMENT ON (B)(6)2018. THEY UNDERWENT LEFT KNEE REVISION ON (B)(6)2023, APPROXIMATELY 4 YEARS 2 MONTHS AFTER THEIR INITIAL IMPLANTATION. POSTOPERATIVE DIAGNOSIS: FAILED LEFT TOTAL KNEE POLYETHYLENE DUE TO PREMATURE WEAR AND POLY RECALL, AS WELL AS OSTEOLYSIS OF THE LEFT FEMORAL COMPONENT. THERE WERE WELL-FIXED TIBIAL AND PATELLAR COMPONENTS. THERE WAS A LOOSE FEMORAL COMPONENT THAT WAS LOOSE FROM THE CEMENT MANTLE. THERE WAS MODERATE POLYETHYLENE WEAR VISIBLE AND PALPABLE WITHIN THE TIBIAL POLYETHYLENE. THERE WAS ALSO FOUND TO BE POLYETHYLENE DEBRIS ENCAPSULATED WITHIN THE SYNOVIUM. THE CEMENT MANTLE WAS FOUND TO REMAIN ON THE FEMUR AND THERE WAS NO CEMENT ADHERENT TO THE BACK SIDE OF THE FEMORAL COMPONENT. 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

  MAUDE report 17139908 ↗
• InjuryMay 2, 2023Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS 73 Y/O MALE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE RECALL, PATIENT WAS REVISED TO A 4.5/15 MM PS INSERT. REASON FOR REVISION IS UNKNOWN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, LAWYER KEPT THEM. X-RAYS ARE NOT AVAILABLE.

  Patient problems: Failure of Implant; Inflammation; Synovitis

  MAUDE report 16852962 ↗

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-