ATTUNE 2512-14-030Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION CEMENTED STEM TRIAL 14mm X 30mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295477792), received between Aug 13, 2018 and Apr 3, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material4
- Appropriate Device Problem Term/Code Not Available1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2024Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT AFTER A SURGERY THEY SAW ON THE X-RAY SOME DAYS POST-OP THAT THEY LEFT AN INSTRUMENT IN THE BONE. TRIAL-TIBIALSTEM WAS STILL IN THE BONE.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19035120 ↗MalfunctionDec 19, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL IS SCRATCHED. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16005405 ↗MalfunctionDec 19, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL IS SCRATCHED. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16005341 ↗MalfunctionDec 19, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIALS WERE SCRATCHED. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16005319 ↗MalfunctionDec 19, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE TRIAL IS SCRATCHED. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16005282 ↗MalfunctionAug 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT SURGEON ALWAYS TAKES A POSTOPERATIVE X-RAY. IT WAS NOTICED THAT THE TRIAL CEMENTED STEM WAS STILL INSIDE THE FEMORAL CANAL. IT CAME LOOSE FROM THE REAMER DURING PREPARATION. NO SURGICAL DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 7777488 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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