ATTUNE 2545-00-653Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 5 8mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE shim is a small orthopedic spacer used in joint replacement surgery. The 47 reports describe the shim breaking, cracking, or bending — several times snapping in half during surgery and being discarded, with no reported injuries or deaths. Reports dropped from 14 in the prior 12 months to 2 in the most recent 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10603295133452), received between Sep 26, 2017 and Jun 8, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Break” (40 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
- Break40
- Crack4
- Naturally Worn3
- Fracture2
- Material Deformation2
- Component Missing1
- Device-Device Incompatibility1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient14
- No Information4
- Insufficient Information1
- No Code Available1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428333 ↗MalfunctionApr 23, 2026Break; Crack
IT WAS REPORTED THAT WHEN TAKING THE 8MM SHIM OFF THE DOG BONE THE SHIM BROKE IN HALF DUE TO A CRACK ALREADY BEING ON THERE. THE DRILL STOPPED AND ALSO HAD A CRACK AND BROKE WHEN TOO MUCH FORCE WAS APPLIED TO THE DRILL FOR THE TIBIA. BOTH BROKEN PIECES WERE THROWN AWAY BY STERILE PROCESSING (SPD) BEFORE WE COULD RETRIEVE THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24971647 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437328 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23428006 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427998 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427995 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427965 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427731 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427624 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427622 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427594 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427590 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427519 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS. THE SPRINGS WERE WORN BECAUSE THEY ARE FREQUENTLY USED TO OPEN THE DOG BONE AND BALANCED SIZER NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460142 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT THE BROKEN TRIAL SHIM AND RP TOP WERE BROKEN BY HITTING WITH A MALLET IN OR. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20822574 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED, THAT ON AN UNKNOWN DATE. THERE WERE BROKEN INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20685601 ↗MalfunctionJun 19, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE 2 SHIMS WERE DROPPED ON THE FLOOR AND THE HOSPITAL STAFF DISPOSED OF THEM. THIS DID NOT DELAY SURGERY. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570582 ↗MalfunctionApr 12, 2023Break; Break
IT WAS REPORTED THE INSTRUMENT ARE BROKEN. THERE IS NO DESCRIPTION OF HOW THE DAMAGE OCCURRED OR THE EXTENT OF THE DAMAGE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16728995 ↗MalfunctionFeb 16, 2023Break; Break
IT WAS REPORTED THAT ALL PIECES WERE BROKEN DURING STERILIZATION. TWO FB ARTICULATION SURFACES WERE BROKEN IN HALF. ONE ARTICULATION SURFACE BROKE OFF AND A PIECE IS STUCK IN THE SHIM WHICH IS ALSO BEING SENT BACK. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16389931 ↗MalfunctionNov 21, 2022Break; Break
IT WAS REPORTED THAT THE SHIM BROKE IN HALF. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15834039 ↗MalfunctionNov 8, 2022Break; Break
IT WAS REPORTED THAT THE INSERT TRIAL AND SHIM BROKE WHEN SURGEON WAS TAKING THE TRIAL OUT WITH A RETRACTOR. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15752355 ↗MalfunctionMay 13, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT MULTIPLE INSTRUMENTS CRACKED AND BROKE DURING THE PROCEDURE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14397852 ↗MalfunctionMar 16, 2022Break; Break
IT WAS REPORTED THAT THE BROKEN INSTRUMENT SCRUB TECH ATTEMPTED TO PUT THE SHIM ON THE SPACER BLOCK AND THE SHIN SNAPPED IN HALF, REPLACEMENT NEEDED. THIS ITEM WAS NEVER PLACED INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13790600 ↗MalfunctionMar 15, 2022Break; Break
TRIAL IS BROKEN IN TWO PARTS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13771968 ↗MalfunctionDec 28, 2021Break; Break
IT WAS REPORTED THAT THE SHIM AND POLY BROKEN DURING TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13094628 ↗
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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