ATTUNE 2545-00-691Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 9 5mm · 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 surgical sizing tool used during knee replacement. Of its 90 reports, 1 involves an injury and no deaths are recorded. Reports mostly describe the instrument breaking, cracking, or parts coming loose, and most describe no clinical signs or impact on the patient. There were 2 reports in the last 12 months, down from 8 before. 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
- 90
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 10603295133636), received between Jun 30, 2017 and Apr 3, 2026 — classified as 1 injury, 89 malfunctions.
The most frequently reported specific device problem is “Break” (53 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
- Break53
- Crack22
- Detachment of Device or Device Component18
- Device-Device Incompatibility6
- Component Missing3
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- No Consequences Or Impact To Patient36
- Insufficient Information7
- No Information4
- No Code Available2
Recent adverse event reports
The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780623 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT THE BITS FROM ATTUNE KIT ARE BROKEN. THERE WAS NO SURGERY DELAY OR PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521833 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT THE SHIMM HAD BROKEN WHEN PROCESSING TRAY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964694 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIM SZ9 5MM WAS BROKEN/ CHIPPED. THE BASEPLATE INSERTER ROD WAS BROKEN. THE EXCEL T-HANDLE WAS BROKEN. THE ACTIS RETAINING STEM INSERTER WAS BROKEN AT BOTTOM. THE PINNACLE STRAIGHT GRATER HNDL CAME APART. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346916 ↗MalfunctionJun 19, 2025Break; Break
IT WAS REPORTED THE INSTRUMENT BROKE INTO TWO (2) PIECES PRIOR TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292781 ↗MalfunctionJun 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE SHIM SZ9 5MM WAS MISSING THE METAL RING. SHIM CANNOT CONNECT TO INSERT TOP WHEN SURGEON IS TRIALLING IMPLANTS FOR KNEE REPLACEMENT. NOTICED DURING SURGERY, HOWEVER INSTRUMENT WAS NOT NEEDED FOR THE PROCEDURE SO THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO DELAY TO SURGERY, NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22161857 ↗MalfunctionJun 2, 2025Break; Break
IT WAS REPORTED THAT A SHIM FROM A CONSIGNMENT TRAY WAS BROKEN; AT THE RAISED SILVER DISC FOR ATTACHMENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126366 ↗MalfunctionMay 6, 2025Break; Break
IT WAS REPORTED THAT THE 9/10 5MM SHIM BROKE DURING TRIALING. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21971426 ↗MalfunctionApr 3, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21761155 ↗MalfunctionDec 2, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE INSTRUMENT WAS BROKEN INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20818323 ↗MalfunctionMay 16, 2024Break; Break
IT WAS REPORTED THAT INSTRUMENT BROKE ON BACK TABLE WHILE SNAPPING TOGETHER. THIS WAS NOT DONE NEAR PATIENT. ALL 3 BROKEN PIECES REMOVED FROM BACK TABLE. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19331806 ↗MalfunctionMay 13, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY. B. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO HARM. C. DID THE INSTRUMENT BROKE INTO 2 OR MORE PIECES? TIBIAL TRIAL WAS IN 2 PIECES. BOTH RETRIEVED EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298325 ↗MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT BOTH SIZE 9/10 BY 5MM SHIMS HAD THE METAL RING THAT CLIPS INTO THE POLY TRIAL FALL OUT RENDERING THEM UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274120 ↗MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT BOTH SIZE 9/10 BY 5MM SHIMS HAD THE METAL RING THAT CLIPS INTO THE POLY TRIAL FALL OUT RENDERING THEM UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19274115 ↗MalfunctionApr 11, 2024Break; Break
IT WAS REPORTED THAT THE METAL RING FELL OUT OF SHIM WHEN TAKING IT OFF OF THE SPACER BLOCK. SHIM WAS DISCARDED BY FACILITY. ALL PIECES WERE RETRIEVED. NOTHING FURTHER TO REPORT.
Patient problems: Insufficient Information
MAUDE report 19087683 ↗MalfunctionMar 27, 2024Crack; Crack
IT WAS REPORTED THAT THERE WAS A CRACK ON THE ATTUNE SHIM AND THE KNOB OF THE INSTRUMENT HAS SNAPPED OFF PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18985655 ↗MalfunctionMar 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL RING ON SHIM FELL OUT UPON INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18970237 ↗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 18874766 ↗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 18874591 ↗MalfunctionFeb 9, 2024Break; Break
IT WAS REPORTED THAT THERE IS A BROKEN/CHIPPED PEG ON THE 41 MM OVAL DOME PATELLA TRIAL AND CHIPPED SHIM SIZE 9/10 - 5MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18675685 ↗MalfunctionSep 29, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT SHIM BROKE INTO TWO DURING EXTRACTIONS. NOTHING WAS LEFT IN PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17844977 ↗MalfunctionJul 28, 2023Break; Break
IT WAS REPORTED THAT THE SHIM WAS FOUND BROKEN BEFORE CASE STARTED. IT DID NOT AFFECT THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17413641 ↗MalfunctionJul 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL SLEEVE INTERFACE IN THE SHIM WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17300334 ↗MalfunctionApr 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716614 ↗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 16690518 ↗
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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