ATTUNE 2545-00-917Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 3 12mm · 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 reusable template used to size implants during surgery. The 34 reports mostly describe the shims breaking or cracking around the metal inserts, often found while assembling sets or during sterilization without patient involvement. There are no deaths and no injuries, and 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295134947), received between Nov 9, 2017 and Nov 18, 2025 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (24 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
- Break24
- Crack13
- Detachment of Device or Device Component4
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient10
- Insufficient Information4
- No Information1
Recent adverse event reports
The 25 most recent of 34 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 23582231 ↗MalfunctionNov 8, 2024Crack; Crack
IT WAS REPORTED ON (B)(6) 2024 WHILE PUTTING SET TOGETHER, CRACKS WERE FOUND IN A 3/4 12MM SHIM. IT WAS NOT USED IN THE CASE. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE ATTUNE CONV SHIM SZ3 12MM WAS FOUND BROKEN AROUND THE RIGHT METAL INSERT AND IT WAS OBSERVED CRACKED AROUND THE LEFT METAL INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20644018 ↗MalfunctionAug 9, 2024Break; Break
IT WAS REPORTED THAT THE SHIMS ARE BROKEN.
Patient problems: Insufficient Information
MAUDE report 19947895 ↗MalfunctionAug 9, 2024Break; Break
IT WAS REPORTED THAT THE SHIMS ARE BROKEN.
Patient problems: Insufficient Information
MAUDE report 19947893 ↗MalfunctionJun 18, 2024Break; Break
IT WAS REPORTED THAT THE SHIMS WERE FOUND TO BE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563236 ↗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 18875070 ↗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 18874704 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT THE SHIM IS BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, 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, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (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 18857114 ↗MalfunctionOct 18, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE IS CRACKED AND CHIPPED. 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 (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 17954633 ↗MalfunctionSep 1, 2023Break; Break
IT WAS REPORTED THAT THE SIZE 3 SIZE 4 12MM SHIM BROKE INTO TWO PIECES WHEN EXTRACTING. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17669520 ↗MalfunctionAug 15, 2023Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17550263 ↗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 17277060 ↗MalfunctionApr 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716515 ↗MalfunctionApr 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716459 ↗MalfunctionApr 11, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16716226 ↗MalfunctionMar 24, 2023Break; Break
IT WAS REPORTED THAT DEVICE HAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16609718 ↗MalfunctionApr 8, 2022Crack; Crack
IT WAS REPORTED THAT THE ATTUNE SHIMS IS PRESENTING CRACKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14052523 ↗MalfunctionApr 1, 2022Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
SPRING IS MISSING FROM THE SPACER BLOCKS. THIS WAS DISCOVERED POST-OP WHILE CLEANSING THE INSTRUMENTS. A SPRING IS CRUSHED ON ANOTHER SPACER BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13976332 ↗MalfunctionMar 30, 2022Break; Break
THE SHIM BROKE, ALL PIECES RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13953141 ↗MalfunctionJan 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS AN EMAIL RECEIVED FROM ORTHO TECH WITH 2 BROKEN INSTRUMENTS THAT NEED REPLACING. BOTH THESE INSTRUMENTS ARE SHIMS FOR THE ATTUNE KNEE SYSTEM. BOTH SHIMS HAVE LOST THE CIRCULAR METAL LINER THAT ALLOWS THE SHIM TO CLIP ONTO THE ARTICULATING SURFACE. THE SHIM ITSELF IS INTACT AND IN ONE PIECE BUT CAN NO LONGER FUNCTION WITHOUT THE METAL INSERT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13307090 ↗MalfunctionJan 4, 2022Break; Break
IT WAS REPORTED THAT WHILE TRIALING, THE INSERT BROKE. ALL PIECES WERE RETRIEVED AND REMOVED FROM PATIENT. NO SURGICAL DELAY NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13151089 ↗MalfunctionMar 16, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT ALL THE INSTRUMENTS ARE BROKEN THROUGH THE MAIN BODY. THE DRILL BITS ARE BENT OUT OF SHAPE AND ALL INSTRUMENTS REMAIN IN ONE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11493099 ↗MalfunctionNov 30, 2020Use of Device Problem; Use of Device Problem
NURSES REPORTED AN ATTUNE SHIM THAT IS MISSING AN INNER METAL RING, REQUIRES REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10920217 ↗MalfunctionNov 4, 2020Break; Break
IT WAS REPORTED THAT THE POLY AND SHIMS HAD PIECES BROKEN OFF. ALL PIECES RETRIEVED. NO SURGICAL DELAY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10788002 ↗MalfunctionApr 6, 2020Break; Break
BROKEN ATTUNE SHIMS AND FEMORAL TRIAL REPORTED BY CSSD STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929806 ↗
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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