ATTUNE 2549-00-100Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION PINNING & SPACING CASE · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295476498), received between Aug 22, 2019 and Apr 23, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated4
- Break3
- Crack1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENTS HAD AN UNKNOWN ALLEGATION. THIS WAS FOUND WHEN INSPECTING PANS THAT WERE RETURNED FROM SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967364 ↗MalfunctionMar 20, 2026Break; Peeled/Delaminated
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. THE PLASTICS WERE DAMAGED AND THERE WAS PEELING OF THE METAL. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653016 ↗MalfunctionJan 6, 2026Break; Peeled/Delaminated
IT WAS REPORTED THAT THE SETS ARE PEALING, AND BROKEN INSERTS. IT WAS REPORTED THAT IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23980940 ↗MalfunctionFeb 5, 2025Crack; Peeled/Delaminated; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE HOSPITAL IS COMPLAINING ABOUT TRAYS DUE TO CHIPPING, PEELING, CRACKING AND OUTER RUBBER PEELING OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312326 ↗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 8920720 ↗
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
- n.a. 39501XKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- Medical Action Industries 6810Medical Action Industries Inc. · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501BECKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
- n.a. 39501XKKarl Storz GmbH & Co. KG · TRAY, SURGICAL, INSTRUMENT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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