ATTUNE 2545-00-928Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 5 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 sizing tool used during knee replacement surgery. Its 79 reports, with no deaths and no injuries, all describe malfunctions, mostly the shim breaking or cracking. Some reports say pieces broke off during a trial fitting and were retrieved, and others say parts were found cracked or missing after washing. 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
- 78
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 10603295135050), received between Jun 22, 2017 and Apr 16, 2026 — classified as 78 malfunctions.
The most frequently reported specific device problem is “Break” (63 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
- Break63
- Crack16
- Detachment of Device or Device Component7
- Scratched Material3
- Component Missing2
- Device-Device Incompatibility2
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- No Consequences Or Impact To Patient26
- No Information5
- Insufficient Information4
- No Code Available1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT THE SZ 5-6 X 10MM SHIM BROKE WHILE TRIALING. BOTH PIECES RETRIEVED. 1 MINUTE LOST TIME.
Patient problems: Insufficient Information
MAUDE report 24903521 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT SHIM WAS BROKEN INTO TWO (2) PIECES. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24616590 ↗MalfunctionFeb 2, 2026Break
IT WAS REPORTED THAT SURGEON BROKE THE ARTICULAR SURFACE WHEN TRYING TO EXTRACT THE TRIALS. IT WAS REPORTED THAT THE ARTICULAR TRIAL WAS SPLIT INTO TWO PIECES AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24229499 ↗MalfunctionDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ATTUNE 5/6 16MM SHIM IS CRACKED. ATTUNE 5/6 10MM SHIM IS MISSING METAL CYLINDERS (CYLINDERS ARE LOST AND WILL NOT BE RETURNED). ATTUNE 38 DOME PATELLA TRIAL SCRATCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23759470 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437329 ↗MalfunctionAug 21, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE ITEMS WERE FOUND BROKEN/CRACKED IN THE TRAY ASSEMBLY AFTER GOING THROUGH THE WASH. ISSUE DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22859125 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THE SHIM BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140842 ↗MalfunctionMay 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE METAL RINGS FALLEN OUT IN WASHER. NO WAS PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21985010 ↗MalfunctionJan 21, 2025Break; Break
IT WAS REPORTED THAT PIECE WAS NOTICED BROKEN BEFORE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21197611 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT SPD STAFF ADVISED THAT SHIMS WERE CRACKED AND/OR BROKEN AND NEED REPLACED TO ENSURE THOROUGH STERILIZATION. THERE WAS NO DELAY IN CASE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20821293 ↗MalfunctionSep 12, 2024Break; Break
IT WAS REPORTED THAT POLY TRIAL BROKE WHILE TRAILING.
Patient problems: Insufficient Information
MAUDE report 20199708 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT THE SHIM BROKE WHEN TRIALING. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20084570 ↗MalfunctionMay 9, 2024Crack; Detachment of Device or Device Component; Scratched Material; Crack; Detachment of Device or Device Component; Scratched Material
IT WAS REPORTED THAT THE ATTUNE SHIM WAS FOUND CRACKED AROUND BOTH METAL BUSHINGS AND WITH SCRATCHES ON OVERALL DEVICE. METAL BUSHING WAS FOUND FALLEN APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281677 ↗MalfunctionApr 25, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED BY SPD DUE TO BROKEN PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19179830 ↗MalfunctionApr 22, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED BY SPD DUE TO BROKEN PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19159653 ↗MalfunctionMar 23, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966094 ↗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 18875077 ↗MalfunctionMar 11, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENTS, IT WAS FOUND THAT TWO OF THE SIZE 5-6 10MM SHIMS WERE NON USABLE. ONE OF THE INSTRUMENT HAD AN INNER PIECE THAT SHIM SNAPS INTO BROKEN MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18873520 ↗MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18841670 ↗MalfunctionMar 5, 2024Break; Crack; Break; Crack
THIS INSTRUMENT IS COMPOSED OF 1 PART. THE INSTRUMENT CONTAINS CRACKS AND IS CHIPPED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18838813 ↗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 18628546 ↗MalfunctionJan 12, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE 10MM SHIMS HAVE CRACKS AND ONE BROKE INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502649 ↗MalfunctionDec 7, 2023Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR IS CRACKED AND SHIM BROKE INTO 3 PIECES. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18282182 ↗MalfunctionOct 20, 2023Break; Crack; Break; Crack
IT WAS REPORTED THA SALES REP WAS ALERTED BY SPD ON A CRACKED SHIM. IT DID NOT HAPPEN IN SURGERY AND NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17975157 ↗MalfunctionMay 26, 2023Break; Break
IT WAS REPORTED THAT DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009769 ↗
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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