ATTUNE 2545-00-693Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 9 8mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE shim is a spacer used during knee replacement surgery as part of the trial instruments surgeons use to size the implant before the real part goes in. The 30 reports mostly describe shims and trial posts breaking or cracking, sometimes while being handled or removed during surgery, and metal connector pieces going missing. No deaths and no injuries are described. There are no recalls naming this device, and reports have slowed sharply, with none in the past 12 months.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295133650), received between Aug 31, 2017 and Jul 22, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (25 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break25
- Crack6
- Detachment of Device or Device Component3
- Device-Device Incompatibility2
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient9
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2025Break; Break
THE ORTHO TECH REPORTED THAT THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22563939 ↗MalfunctionOct 14, 2024Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, WHILE BEING REMOVED FROM THE PATIENT, THE SIZE 9/10 8MM SHIM WAS BROKEN INTO TWO PIECES. THE TRIALING STAGE OF THE PROCEDURE WAS COMPLETE, SO THE SHIM WAS NO LONGER NEEDED. BOTH PIECES WERE REMOVED FROM THE FIELD, AND SURGICAL TIME WAS NOT EXTENDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20439913 ↗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 18874686 ↗MalfunctionDec 11, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18307658 ↗MalfunctionOct 30, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY. PER FINDINGS ON THE VISUAL INSPECTION OF THE RETURNED DEVICES THEY WERE BROKEN AND CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18028490 ↗MalfunctionApr 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE WHITE TRIAL POSTS WERE BOTH DAMAGED AND THE SHIMS DON'T HOLD TO INSERT TRIAL WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16690539 ↗MalfunctionApr 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE WHITE TRIAL POSTS WERE BOTH DAMAGED AND THE SHIMS DO NOT HOLD TO INSERT TRIAL WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16690452 ↗MalfunctionApr 5, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE TRIAL HAS CRACKS AND CHIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681934 ↗MalfunctionMar 28, 2023Break; Break
IT WAS REPORTED THAT THE SIZE 9-10 X 8MM SHIM BROKE WHILE TRIALING. ALL PIECES WERE RECOVERED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16626396 ↗MalfunctionDec 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT SHIM SPRINGS ARE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15962782 ↗MalfunctionNov 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED DURING INSTRUMENT INSPECTION IT WAS NOTICED THAT THE METAL INSERTS IN THE SHIM HOLES ARE MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15840585 ↗MalfunctionAug 5, 2022Break; Break
IT WAS REPORTED THAT AN EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED IN CSSD. EMAIL CONTAINS ALL ITEMS FROM CONSIGNMENT SETS. NO INFORMATION IS PROVIDED AS TO HOW THE BROKE, OR THE EXTENT OF DAMAGE THAT HAS BEEN INCURRED. ITEMS ONLY CONTAIN BATCH CODES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15173680 ↗MalfunctionJul 27, 2022Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
INSTRUMENTS ARE BROKEN. NO ADVERSE AFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15115354 ↗MalfunctionJul 11, 2022Break; Break
IT WAS REPORTED THAT THESE INSTRUMENTS ARE BROKEN AND REQUIRE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14976944 ↗MalfunctionJun 28, 2022Break; Break
IT WAS REPORTED THAT THE 9/10 8MM SHIM BROKE DURING TRIAL REMOVAL. SURGICAL DELAY OF 2 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14844796 ↗MalfunctionJun 15, 2022Break; Break
IT WAS REPORTED THAT WHILE CHANGING SHIMS, SCRUB NURSE SNAPPED TWO OF THEM IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14697871 ↗MalfunctionMay 7, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE INSTRUMENT HAS BEEN REPORTED FOR CRACKING/BEING BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14315297 ↗MalfunctionJul 27, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAS BEEN BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12226524 ↗MalfunctionMay 7, 2021Break; Break
IT WAS REPORTED THAT UPON REMOVING THE TIBIAL ARTICULATING SURFACE TRIAL, THE SHIM CRACKED. NO PARTS REMAINED NOR DID IT IMPACT THE SURGERY TIME. FURTHER INFORMATION REPORTED THE SHIM WAS BROKEN INTO 2 PIECES. LOCATION OF BREAK WAS THE EDGE BROKE AT THE METAL RING INSERTION POINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11794400 ↗MalfunctionDec 15, 2020Break; Break
IT WAS REPORTED THAT SHIMS FOUND BROKEN IN STERILE PROCESSING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11009033 ↗MalfunctionApr 1, 2020Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE DEVICES DID NOT BREAK. ONLY A SMALL CRACK WAS FOUND ON EACH DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9909186 ↗MalfunctionJan 29, 2020Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN WHILE REMOVING AFTER TRIALING. TWO PIECES AND ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9643706 ↗MalfunctionAug 13, 2019Break; Break
IT WAS REPORTED THAT BOTH INSTRUMENTS ARE CRACKED. THEY WERE NOT USED IN THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8887899 ↗MalfunctionJul 24, 2019Break; Break
ATTUNE SHIMS HAVE ALL CRACKED AROUND THE METAL INSERT AREA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8821729 ↗MalfunctionMay 30, 2019Break; Crack; Break; Crack
BROKEN INSTRUMENT NOTICED BY CSSD FREMANTLE AND REPORTED. NO IMAGES OR ADDITIONAL DETAIL SUPPLIED BY CSSD FREMANTLE. IF OTHER, DESCRIBE --> BROKEN INSTRUMENTS NOTICED BY CSSD FREMANTLE DURING STERILISATION., IF OTHER, DESCRIBE --> BROKEN INSTRUMENTS NOTICED BY CSSD FREMANTLE DURING STERILISATION., PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8656058 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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