ATTUNE 2545-00-919Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 3 16mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295134961), received between May 18, 2018 and Nov 18, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (19 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
- Break19
- Crack3
- Material Integrity Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient8
- Insufficient Information1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT THE SHIM TRIALS WERE BROKEN DURING STERILIZATION PROCESS. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582394 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT SPD STAFF ADVISED THAT SHIMS WERE CRACKED AND/OR BROKEN AND NEED REPLACED TO ENSURE THOROUGH STERILIZATION. THERE WAS NO DELAY IN CASE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20821314 ↗MalfunctionAug 27, 2024Break; Break
IT WAS REPORTED THAT INSERT TRIAL BROKE WHILE TRAILING.
Patient problems: Insufficient Information
MAUDE report 20075811 ↗MalfunctionJul 7, 2023Break; Break
IT WAS REPORTED THAT THE SHIM TRIALS WERE FOUND TO HAVE CRACKS IN THEM. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17277048 ↗MalfunctionJul 7, 2023Break; Break
IT WAS REPORTED THAT THE SHIM TRIALS WERE FOUND TO HAVE CRACKS IN THEM. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17277042 ↗MalfunctionMay 1, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT A LIST OF BROKEN INSTRUMENTS WERE SUBMITTED WITHOUT DESCRIPTION OF HOW THE ITEMS BROKE OR THE EXTENT OF THE DAMAGE THAT HAS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843246 ↗MalfunctionJan 31, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16274969 ↗MalfunctionJan 31, 2023Break; Break
EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN CONSIGNMENT ATTUNE INSTRUMENTS. EMAIL CONTAINED ONLY THE REF CODES FOR THE SHIMS. THERE WAS NO OTHER DETAILS PROVIDED. NO LOT CODES WERE ALSO PROVIDED. REP ONSITE ON TUESDAY AND WILL CHASE UP LOT CODES. NO DESCRIPTION OF DAMAGE OR HOW THE DAMAGE OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16274844 ↗MalfunctionAug 15, 2022Break; Break
IT WAS REPORTED THAT A BROKEN SHIM IDENTIFIED PRIOR TO USE FROM ATTUNE TKR SET. NO DELAY AS BACK UP SET UTILIZED, AND THAT PARTICULAR SHIM THICKNESS WAS NOT REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15224791 ↗MalfunctionMar 10, 2022Break; Break
CSSD IDENTIFIED THE BROKEN INSTRUMENTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13721071 ↗MalfunctionAug 26, 2021Break; Crack; Break; Crack
BROKEN CONSIGNMENT INSTRUMENTS, DID NOT HAPPEN INTRAOPERATIVELY, CRACKED INSTRUMENTS. IT WAS REPORTED THAT THE FRONT OF THE SHIM IS CRACKED. THIS IS THE ONLY INFORMATION PROVIDED. IT DID NOT BREAK INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12374443 ↗MalfunctionJan 13, 2021Break; Break
BROKEN INSTRUMENTS SUSTAINED OVER THE CHRISTMAS PERIOD. EMAIL PROVIDES DETAILS OF WHAT INSTRUMENTS ARE BROKEN WITH THE RELEVANT BATCH NUMBERS. THE EMAIL DOES NOT PROVIDE INFORMATION ON WHERE OR HOW THESE INSTRUMENTS BROKE AND IF DEBRIS WAS GENERATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11166820 ↗MalfunctionNov 6, 2020Break; Break
INSTRUMENTS FOUND TO BE BROKEN DURING THE CLEANING AND STERILIZATION PROCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10802118 ↗MalfunctionMar 25, 2020Break; Break
BROKEN ATTUNE SHIM, SROM PIN PUNCH AND BONE SCREW ANGLED DRIVER REPORTED BY CSSD STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9879547 ↗MalfunctionMay 6, 2019Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT THE INSTRUMENTS WAS BROKEN AND DAMAGED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8582217 ↗MalfunctionJan 10, 2019Break; Break
IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT ADVISED THAT A NUMBER OF SHIMS FROM ATTUNE'S SHIMS AND GENERAL TRAY WERE CRACKED AND BROKEN AND COULD NOT BE ADEQUATELY AND SAFELY PROCESSED. IT APPEARS THE SHIMS BROKE DURING THE WASH OR STERILIZER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8235587 ↗MalfunctionSep 19, 2018Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIM BROKE WHILE REMOVING AFTER TRIALING POLY SIZE 3, 16MM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7891079 ↗MalfunctionJul 10, 2018Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7674872 ↗MalfunctionJul 10, 2018Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673340 ↗MalfunctionMay 18, 2018Crack; Crack
IT WAS REPORTED THAT THE SHIM HAS CRACKED AROUND THE METAL INSERT AREA. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7525151 ↗
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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