ATTUNE 2545-00-918Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 3 14mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE conventional shim is a surgical spacer used during knee replacement trials. The 33 reports mostly describe shims and trial posts cracking or breaking — often found damaged in the tray after washing or sterilization, and sometimes bending the alignment rod — with pieces retrieved and no harm to patients. There are no deaths and no injuries. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295134954), received between Nov 9, 2017 and Jun 1, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (29 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
- Break29
- Crack16
- Detachment of Device or Device Component3
- Device-Device Incompatibility1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient8
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT THE SHIM DEVICES WERE BROKEN, THE ALIGNMENT ROD WAS BENT AND THE TRIAL POST DEVICES WERE CRACKED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. THERE WAS NO PATIENT OR USER HARM. THERE WERE NO REPORTS OF SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351298 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THERE WERE BROKEN TRIAL SHIMS, BENT ALIGNMENT ROD, CRACKED TRIAL POST.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25096137 ↗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 23582314 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437323 ↗MalfunctionAug 21, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE ITEMS WERE FOUND BROKEN/CRACKED IN THE TRAY ASSEMBLY AFTER GOING THROUGH THE WASH. ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859126 ↗MalfunctionAug 14, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY, AND THE INSTRUMENTS WERE CRACKED/CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806692 ↗MalfunctionFeb 10, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THERE WAS A SPLIT/CRACK IN TWO ATTUNE SHIMS. THERE WAS NO PATIENT DELAY; THE ISSUE WAS IDENTIFIED OUTSIDE OF THE THEATRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343228 ↗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 20821364 ↗MalfunctionMar 11, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SHIMS WERE CRACKED/MISSING METAL CONNECTING PIECES.
Patient problems: Insufficient Information
MAUDE report 18875066 ↗MalfunctionJul 5, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SHIMS WERE FOUND TO HAVE CRACKS IN THEM. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17255134 ↗MalfunctionMay 1, 2023Break; Break
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 16843249 ↗MalfunctionApr 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716649 ↗MalfunctionApr 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716249 ↗MalfunctionSep 16, 2022Break; Break
IT WAS REPORTED AS A LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED IN CSSD OVER COURSE OF THE WEEK. INSTRUMENTS ARE ALL FROM CONSIGNMENT SETS. THE LIST CONTAINS MATERIAL ITEM NUMBERS BUT NO DESCRIPTION AS TO HOW THEY BROKE OR THE EXTENT OF THEIR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15438461 ↗MalfunctionMay 9, 2022Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
THE SHIM IS NICKED. IT WILL NOT FIT OVER EVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14337058 ↗MalfunctionApr 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED AS BROKEN ATTUNE SPACER SHIM. METAL WASHERS HAVE FALLEN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13976310 ↗MalfunctionJan 20, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPACER TRIALS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306661 ↗MalfunctionJan 20, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPACER TRIALS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306660 ↗MalfunctionJan 20, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPACER TRIALS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306659 ↗MalfunctionJan 20, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPACER TRIALS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306658 ↗MalfunctionJan 20, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPACER TRIALS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306657 ↗MalfunctionJan 20, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SPACER TRIALS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13306655 ↗MalfunctionDec 3, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
ATTUNE SHIM HAS CRACKED AROUND THE METAL INSERT AREA. ALSO ON TWO OF THE SHIMS THE METAL INSERT HAS STATED TO COME OUT OF SHIM BODY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923759 ↗MalfunctionDec 29, 2020Break; Break
EMAIL RECEIVED FROM CSSD CO-ORDINATOR AT (B)(6) WITH A WEEKLY UPDATE OF INSTRUMENTS THAT HAVE BEEN FOUND TO BE BROKEN FOLLOWING THE CLEANING AND STERILISATION PROCESS. THE HOSPITAL HAS PROVIDED THE DETAILS OF THE BROKEN INSTRUMENTS, HOWEVER, THE CASE THEY WERE INVOLVED IN, HOW THEY BROKE IS ALL UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11089465 ↗MalfunctionJun 11, 2020Crack; Crack
IT WAS REPORTED THAT THE ATTUNE SHIMS ARE CRACKED AND NEEDS TO BE REPLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10143764 ↗
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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