ATTUNE 252307103Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT TRIAL LM/RL 15MM SIZE 7/8 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295437185), received between Aug 2, 2019 and Aug 22, 2025 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Corroded” (8 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
- Corroded8
- Contamination /Decontamination Problem2
- Device-Device Incompatibility1
- Improper or Incorrect Procedure or Method1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PROPERLY FIX THE THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. THE THREADS OF THE TRIAL APPEAR TO BE COLD WELDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22878237 ↗MalfunctionJun 28, 2024Corroded; Corroded
IT WAS REPORTED THAT THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST. THIS WAS PICKED UP POST CLEANING BY CSSD STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633877 ↗MalfunctionMar 28, 2024Corroded; Corroded
IT WAS REPORTED THAT INSTRUMENTS WERE RUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997920 ↗MalfunctionOct 25, 2023Corroded; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Corroded; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE FEMORAL TRIAL HAS STARTED TO RUST DUE TO INCORRECT DETERGENT USED AT THE HOSPITAL. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF ? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST? TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18007521 ↗MalfunctionSep 29, 2022Corroded; Corroded
IT WAS REPORTED THAT THE DEVICES ARE RUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15508433 ↗MalfunctionJul 22, 2022Corroded; Corroded
IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15085859 ↗MalfunctionJun 24, 2022Corroded; Corroded
IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14799637 ↗MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
STERILE SERVICES IDENTIFIED MULTIPLE INSTRUMENTS WITH RED RESIDUE PRESENT, MAINLY AFFECTING TIBIAL TRIALS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12443970 ↗MalfunctionAug 2, 2019Corroded; Corroded
INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8856166 ↗MalfunctionAug 2, 2019Corroded; Corroded
INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8856164 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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