ATTUNE 2545-00-916Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 3 10mm · 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 temporary instrument used during knee replacement surgery to check spacing and alignment before the real implant goes in. The 55 reports mostly describe shims and trial parts breaking or cracking, sometimes with a bent alignment rod or a metal ring falling out, and several were noticed before surgery so surgery was not delayed. No deaths or injuries are reported. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295134930), received between Sep 26, 2017 and Jun 1, 2026 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Break” (47 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
- Break47
- Crack15
- Detachment of Device or Device Component4
- Device-Device Incompatibility2
- Naturally Worn2
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Consequences Or Impact To Patient13
- Insufficient Information3
- No Information2
Recent adverse event reports
The 25 most recent of 55 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 25351294 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT THE PIECE WAS BROKEN. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247042 ↗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 25096101 ↗MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS AND ARTICULATING SURFACE WERE BROKEN AND NEEDED TO BE REPLACED. BROKEN INSTRUMENTS WERE NOT USED IN SURGERY AND THERE WAS NO DELAY CAUSED THEREFROM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888869 ↗MalfunctionNov 17, 2025Break; Break
CHIPPED AND NOT SITTING CORRECTLY ON TIB TRAY NO LOT NUMBERS. NO TIME ADDED ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23567598 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437321 ↗MalfunctionJul 22, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THERE WAS A BROKEN SHIM. THE METAL RING FALLEN OUT SO WILL NO LONGER ATTACH TO ARTICULATING SURFACE. IT WAS NOTICED BEFORE THE CASE SO NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566836 ↗MalfunctionMar 17, 2025Break; Break
IT WAS REPORTED THAT A BROKEN (CRACKED) SHIM WAS FOUND UPON INSPECTION ON FEBRUARY 21 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620510 ↗MalfunctionMar 10, 2025Break; Break
IT WAS REPORTED THAT AN ATTUNE CONV SHIM SZ3 10MM WAS FOUND TO BE SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21562216 ↗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 21343231 ↗MalfunctionDec 16, 2024Break; Break
IT WAS REPORTED THAT THE REAMER WAS OLD AND DULL, AND THE TRIAL SHIM WAS BROKEN INTO TWO PIECES NEAR ONE OF THE HOLES. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20937496 ↗MalfunctionOct 7, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE INSTRUMENTS SPRINGS BROKE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384862 ↗MalfunctionMay 31, 2024Break; Break
IT WAS REPORTED THAT THE SHIM BROKE WHILE TRIALING.
Patient problems: Insufficient Information
MAUDE report 19433867 ↗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 18874529 ↗MalfunctionFeb 1, 2024Break; Break
INSTRUMENTS WERE REPORTED FOR UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY. VISUAL EXAM OF THE RETURNED DEVICE FOUND IT TO BE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18628544 ↗MalfunctionJan 29, 2024Crack; Crack
IT WAS REPORTED THAT THE SHIM IS CRACKED. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?-NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY, UNKNOWN, (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 18595810 ↗MalfunctionJan 11, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE 10MM SHIMS HAVE CRACKS AND ONE BROKE INTO (B)(4) PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18498787 ↗MalfunctionDec 11, 2023Break; Break
IT WAS REPORTED THAT SHIM BROKE. 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 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 18306718 ↗MalfunctionNov 16, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE FEMORAL IMPACTOR AND ATTUNE SIZE 3-4 10MM SHIM WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18147953 ↗MalfunctionNov 16, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE FEMORAL IMPACTOR AND SZ 3/4 10MM SHIM ARE BROKEN AND WORN. DETECTED BY CSSD STAFF POST OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18147765 ↗MalfunctionSep 7, 2023Break; Break
IT WAS REPORTED THAT ONE PIECE OF THE SZ 3 10MM SHIM BROKE OFF WHEN EXTRACTING THE TRIAL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17697985 ↗MalfunctionJul 27, 2023Crack; Crack
IT WAS REPORTED THAT SHIM TRIAL CRACKED WHEN BEING REMOVED FROM SPACER BLOCK FOR CLEANING. NO PIECES WERE LEFT BEHIND. NO HARM TO PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17405656 ↗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 17258568 ↗MalfunctionJun 22, 2023Break; Break
IT WAS REPORTED THAT THE SHIM TRIAL SPLIT. ALL PIECES RETRIEVED. THERE WAS NO SURGICAL DELAY. NO HARM TO PATIENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181330 ↗MalfunctionJun 7, 2023Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN INTO TWO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17079551 ↗
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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