ATTUNE 2513-16-110Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM REVISION PRESS-FIT STEM TRIAL 16mm x 110mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 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 10603295438847), received between Jan 17, 2022 and Aug 26, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Naturally Worn2
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.
MalfunctionAug 26, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE REVISION STEM THREADS WERE DAMAGED AND WOULD NOT THREAD ONTO FEMORAL BOSS REAMER. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15305028 ↗MalfunctionJan 17, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE THREADS ARE STRIPPED. DOES NOT THREAD INTO TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13266592 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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