ATTUNE 2545-01-803Recalls & reported problems
Depuy (Ireland) · ATTUNE MI SPACER BLOCK · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295432326), received between Dec 12, 2018 and Apr 1, 2025 — classified as 7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component2
- Separation Problem2
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE INSTRUMENT WAS MISSING A SPRING, THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21742234 ↗MalfunctionAug 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SHIM WILL NOT STAY ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20047755 ↗MalfunctionJun 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING CAME OFF WHERE SHIM CONNECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476720 ↗MalfunctionFeb 26, 2024Break; Break
IT WAS REPORTED THAT SPRINGS BROKE OFF. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18785483 ↗MalfunctionDec 22, 2021Break; Break
SEAL BROKE WHERE SHIN CONNECTS TO METAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13061247 ↗MalfunctionDec 12, 2018Separation Problem; Separation Problem
IT WAS REPORTED THAT THE SPD BROUGHT TO MY ATTENTION THAT AFTER RETRIEVING INSTRUMENT FROM WASHER THAT THE SPRING DETACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8156270 ↗MalfunctionDec 12, 2018Separation Problem; Separation Problem
IT WAS REPORTED THAT THE SPD BROUGHT TO MY ATTENTION THAT AFTER RETRIEVING INSTRUMENT FROM WASHER THAT THE SPRING DETACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8156250 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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