ATTUNE 2545-00-631Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 3 5mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE shim, a small spacer used during knee replacement surgery, is the subject of 33 adverse event reports, all describing malfunction with no deaths and no injuries. Reports mostly describe the shim breaking, cracking, or snapping in two during surgery, sometimes as it was being removed, with fragments retrieved in most cases and no reported effect on the patient. 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 10603295133339), received between Jan 23, 2018 and Feb 5, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Break” (26 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
- Break26
- Crack2
- Material Integrity Problem2
- Component Missing1
- Material Deformation1
- Material Twisted/Bent1
- Naturally Worn1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- No Consequences Or Impact To Patient11
- No Code Available1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2026Break
IT WAS REPORTED, DURING SURGERY AN ATTUNE SHIM BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270689 ↗MalfunctionDec 2, 2025Break; Break
SHIM HAS SNAPPED IN TWO ALL PARTS RETRIEVED NO TIME ADD ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692385 ↗MalfunctionNov 13, 2025Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO ATTUNE SHIM DEVICES WERE BROKEN IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544674 ↗MalfunctionNov 5, 2025Break; Break
IT WAS REPORTED THAT WHEN EXTRACTING THE TIBIAL TRIAL, THE ATTUNE SHIM SZ3 5MM DEVICE 3-4 5MM SHIM WAS BROKEN IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477339 ↗MalfunctionMar 31, 2025Break; Break
IT WAS REPORTED THAT WHILE TRAILING THE TOTAL KNEE COMPONENTS, THE SZ 3-4 5MM SHIM BROKE IN HALF. BOTH PIECES WERE RETRIEVED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND SURGERY TIME WAS NOT EXTENDED. THERE IS NO MORE INFORMATION AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21734121 ↗MalfunctionNov 5, 2024Break; Break
IT WAS REPORTED, THAT THE 3/4X5MM SHIM SNAPPED IN TWO. WHILE, BEING REMOVED FROM THE PATIENT. ALL FRAGMENTS REMOVED AND WOUND WASHED. NO ADDITIONAL TIME ADDED TO PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20614834 ↗MalfunctionOct 8, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20402123 ↗MalfunctionOct 2, 2024Break; Break
IT WAS REPORTED ON SEPTEMBER 23, 2024 THAT THE 5MM SHIM SNAPPED IN HALF. NO PATIENT CONSEQUENCES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353148 ↗MalfunctionJan 4, 2024Break; Break
IT WAS REPORTED THAT THE TWO INSTRUMENTS BROKE DURING THE CASE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18445175 ↗MalfunctionFeb 9, 2023Break; Break
IT WAS REPORTED THAT THE SHIM BROKE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16338074 ↗MalfunctionJan 27, 2023Break; Break
IT WAS REPORTED THAT THE SHIM IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16251716 ↗MalfunctionDec 6, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING KNEE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15923477 ↗MalfunctionDec 5, 2022Break; Break
IT WAS REPORTED THAT THE SHIM BROKE INTO TWO PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915606 ↗MalfunctionOct 24, 2022Break; Break
IT WAS REPORTED THAT A SIZE 3-4 5MM ATTUNE SHIM OFF OF THE SHIMS AND GENERAL INSTRUMENTS TRAY WAS BROKEN IN HALF WHEN REMOVING FROM AN ARTIC SURF INSERT. ALL BROKEN PIECES WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657675 ↗MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ITEMS WERE INSPECTED BY STAFF AND DEEMED DAMAGED, WILL NOT REPROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14799239 ↗MalfunctionJun 24, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE ITEMS WERE INSPECTED BY STAFF AND DEEMED DAMAGED, WILL NOT REPROCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14799229 ↗MalfunctionMay 9, 2022Break; Break
THE SHIMS WERE DISCOVERED BROKEN PRIOR TO STERILIZATION FOLLOWING THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14337115 ↗MalfunctionApr 21, 2022Break; Break
IT WAS REPORTED THAT WHEN PUTTING THE POLY TRIAL AND SHIM IN, BOTH INSTRUMENTS BROKE IN HALF. THE POLY TRIAL AND THE SHIM BOTH BROKE INTO 2 PIECES. BOTH INSTRUMENTS HAVE BEEN USED IN 50+ SURGERIES. ALL ITEMS WERE REMOVED AND SENT BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167911 ↗MalfunctionApr 12, 2022Break; Break
THE SHIMS ARE BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14086485 ↗MalfunctionNov 22, 2021Break; Break
IT WAS REPORTED THAT THE SHIM BROKE IN HALF. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12853239 ↗MalfunctionJun 24, 2021Crack; Crack
IT WAS REPORTED THAT WHEN SETTING UP FOR THE CASE IT WAS NOTICED THAT THE SIZE 3/4 - 5MM SHIM WAS CRACKED. THE BROKEN INSTRUMENT WAS REMOVED FROM THE STERILE FIELD BEFORE THE CASE BEGAN. NO IMPACT TO PATIENT CARE AND SURGICAL TIME WAS NOT EXTENDED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12057182 ↗MalfunctionNov 25, 2020Break; Break
IT WAS REPORTED THAT THE ATTUNE KNEE ARTIC SURF SIZE 3-4/5MM WAS BROKEN IN 2 PIECES IN DECONTAMINATION. THE INCIDENT DID NOT DELAY SURGERY, NOR DID IT INVOLVE A PATIENT. THE INSTRUMENT WAS BROKEN ON THE BOTTOM LEFT CORNER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10907021 ↗MalfunctionSep 24, 2020Break; Break
BROKEN ATTUNE INSTRUMENTS REPORTED BY (B)(6) STAFF. NO REPORT OF SURGICAL DELAY OR PATIENT CONSEQUENCES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10584292 ↗MalfunctionFeb 28, 2020Break; Material Twisted/Bent; Naturally Worn; Break; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE SHIM IS DAMAGED/WORN FROM NORMAL CASE USAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9771436 ↗MalfunctionOct 28, 2019Crack; Crack
IT WAS REPORTED THAT THE FOLLOWING SHIM TRIALS ARE CRACK AND NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9246394 ↗
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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