ATTUNE 2549-00-080Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION STEM TRIALS CASE · Class 1
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295476504), received between Jul 13, 2018 and Apr 7, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Peeled/Delaminated2
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Peeled/Delaminated
PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE OUTSIDE OF THE PAN WAS PEELING. NO OTHER DETAILS PROVIDED. NO LOT NUMBER WAS PROVIDED, AND THERE WAS NO SURGEON INVOLVED AS THIS WAS DISCOVERED AS A WEAR AND TEAR ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808721 ↗MalfunctionJul 23, 2024Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem
IT WAS REPORTED THAT STEM TRIALS TRAY IS BROKEN AND UNACCEPTABLE FOR STERILIZATION. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804538 ↗MalfunctionAug 22, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated
IT WAS REPORTED THAT THESE TRAYS HAS BEEN SHIPPED ALL OVER THE TERRITORY, THIS HAS CAUSED DAMAGED TO ALL OF THE FOLLOWING INSTRUMENT TRAYS. ALL OF THESE TRAYS WILL NEED TO BE REPLACED. ALL TRAYS HAS BEEN USED IN NUMEROUS SURGERY WITH NO DELAYS, AND NO PATIENT WAS EVER HARMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8920710 ↗MalfunctionJul 13, 2018Break; Break
IT WAS REPORTED THAT THE TRAY WAS DELAMINATING AND PLASTIC STEM HOLDER WAS BROKEN. THIS WAS NOTICED AT TERRITORY OFFICE, NOT AT THE HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7685006 ↗
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- 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.