ATTUNE 252309202Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION TIBIAL AUGMENT TRIAL LL/RM 10MM SIZE 9/10 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295437093), received between Oct 31, 2023 and Jun 28, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Corroded” (2 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
- Corroded2
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 19634050 ↗MalfunctionOct 31, 2023Corroded; Improper or Incorrect Procedure or Method; Corroded; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT REAMER HAS RUSTED DUE TO WRONG DETERGENT USED AT 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, IP-(B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(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 18041319 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 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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