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ATTUNE 2545-00-699Recalls & reported problems

Depuy (Ireland) · ATTUNE SHIM SIZE 9 20mm · 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 10603295133711), received between Jun 1, 2020 and Dec 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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

  • Break2
  • Crack1
  • Naturally Worn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 6, 2022Break; Naturally Worn; Break; Naturally Worn

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE METAL SPRING HAS COME AWAY AND ONE HAS CRACKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15926759 ↗
  • MalfunctionJun 1, 2020Break; Crack; Break; Crack

    BROKEN ATTUNE SHIMS AND LCS RULER REPORTED BY CSSD STAFF.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10106807 ↗

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Sources and updates

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