ATTUNE 2545-11-495Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM CEMENTLESS FIXED BEARING TIBIAL PREP · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295527725), received between May 16, 2023 and Apr 8, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (5 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated5
- Contamination /Decontamination Problem1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE CEMENTLESS FB TIBIAL PREP TRAY WAS BEING REJECTED BY FACILITY DUE TO TRAY CHIPPING COATING FROM THE TRAY. ONLY THE TRAY NEEDS TO BE REPLACED. ALL INSTRUMENTS WERE ACCEPTABLE,.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820804 ↗MalfunctionDec 12, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THE COATING ON PANS ARE PEELING OFF. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23790710 ↗MalfunctionOct 24, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE TRAYS ARE DAMAGED.
Patient problems: Insufficient Information
MAUDE report 20522484 ↗MalfunctionMar 26, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984317 ↗MalfunctionMar 7, 2024Peeled/Delaminated; Peeled/Delaminated
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18855242 ↗MalfunctionFeb 1, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE PAINT WAS PEELING ON TRAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18622654 ↗MalfunctionMay 16, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT AFTER WASHING THE SETS IN THE WASHER THERE WAS A WHITE POWDER/RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16940445 ↗
Other TRAY, SURGICAL, INSTRUMENT devices
- PINNACLE 2220-00-100Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT74 reports
- ACTIS 2010-04-200Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT66 reports
- ATTUNE 2545-01-703Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT62 reports
- ATTUNE 2545-01-704Depuy (Ireland) · TRAY, SURGICAL, INSTRUMENT57 reports
- INSTRUMENT 6541-9-109Howmedica Osteonics Corp. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6805Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501CECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 11580AKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.