Truliant 02-022-35-2012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862304094), received between Jun 27, 2023 and Aug 7, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 35 MONTHS AFTER A LEFT KNEE REPLACEMENT PROCEDURE, THE PATIENT MAY REQUIRE A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, AND DISCOMFORT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 19930971 ↗
• InjuryMay 13, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT KNEE ARTHROPLASTY ON (B)(6) 2019, WITH NO REVISION SURGERY REPORTED. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO OTHER INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 19302091 ↗
• InjuryJun 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO A RECALLED POLY. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17208520 ↗

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-