ATTUNE 2549-00-040Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION GENERAL FEMORAL PREP 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 10603295476139), received between Aug 22, 2019 and Feb 5, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (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
- Peeled/Delaminated3
- Crack2
- Break1
- Contamination /Decontamination Problem1
- Device Contamination with Chemical or Other Material1
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.
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 21312296 ↗MalfunctionFeb 4, 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 21305925 ↗MalfunctionNov 6, 2019Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE PAN HAS CEMENT AND A STICKY SUBSTANCE THAT WILL NOT COME OFF. HOSPITAL NEEDS REPLACEMENT SO THAT IT CAN BE STERILIZED. ALL THE INNER PARTS OF THE TOP NEEDS TO BE REPLACED AS WELL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9284878 ↗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 8920722 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.