ATTUNE 2545-06-017Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM ROTATING PLATFORM TIBIAL BASE IMPACTOR · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295514312), received between Feb 9, 2022 and May 20, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem6
- Scratched Material6
- Break5
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Contamination /Decontamination Problem; Material Integrity Problem
IT WAS REPORTED THAT IMPACTOR WAS DAMAGED, SO CEMENT COULD NOT BE REMOVED FROM THE GROOVES ANYMORE FROM OVER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234077 ↗MalfunctionDec 17, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT ARTIFICIAL KNEE REPLACEMENT FOR KNEE OSTEOARTHRITIS USING RP IMPACTORS. DURING THE TIBIA IMPACTION, THE IMPACTORS BROKE. THE DEVICES WERE REMOVED FROM USE AND THE FRAGMENT RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23826842 ↗MalfunctionOct 24, 2025Break; Break
IT WAS REPORTED THAT A RP IMPACTOR WAS CHIPPED AND NEEDED REPLACING, FROM GENERAL USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379290 ↗MalfunctionFeb 24, 2025Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. THE INSTRUMENTS WERE BROKEN/SCRATCHED UP.
Patient problems: Insufficient Information
MAUDE report 21445474 ↗MalfunctionAug 30, 2024Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS WERE SCRATCHED, DAMAGED, AND BROKEN. THE HOSPITAL REFUSED TO PROCESS DUE TO STERILITY CONCERNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20106634 ↗MalfunctionJul 24, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE SPD DEPARTMENT/STAFF SAYS THE INSTRUMENTS ARE UNABLE TO BE PROPERLY CLEANED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19819171 ↗MalfunctionApr 16, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS ARE SCRATCHED AND UNABLE TO BE CLEANED BY SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115664 ↗MalfunctionApr 16, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS ARE SCRATCHED AND UNABLE TO BE CLEANED BY SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115644 ↗MalfunctionApr 16, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS ARE SCRATCHED AND UNABLE TO BE CLEANED BY SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115611 ↗MalfunctionApr 16, 2024Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS ARE SCRATCHED AND UNABLE TO BE CLEANED BY SPD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19115605 ↗MalfunctionFeb 9, 2022Break; Break
IT WAS REPORTED THAT THE POST ON BUTTON HAS SHEARED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13498120 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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