ATTUNE 2545-11-462Recalls & reported problems
Depuy (Ireland) · ATTUNE KNEE SYSTEM PROTECTION PLATE SPACER BLOCK HANDLE · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295527701), received between Mar 29, 2023 and Dec 23, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Detachment of Device or Device Component1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Break; Break
IT WAS REPORTED THAT THE SPRING ON ATTUNE SPACER BLOCK WAS BROKEN. ALL PIECES RETRIEVED. NO DELAY. NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882668 ↗MalfunctionMay 8, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6), 2025. THE RED KNOBS BROKE OFF OF BOTH INTRODUCERS. POST EDGES BROKE ON SPACER AND WILL NO LONGER HOLD SHIMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988652 ↗MalfunctionMay 23, 2023Break; Break
IT WAS REPORTED THAT THE ATTACHMENT POST BROKE OFF. NO HARM TO THE PATIENT AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16987754 ↗MalfunctionMar 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THAT WHEN ASSEMBLING NEW INSTRUMENT SETS, THE SPACER BLOCK WAS MISSING THE RETENTION SPRINGS ON ALL 4 POST. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16635446 ↗
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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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