ATTUNE 2545-00-932Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 5 18mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295135098), received between Nov 17, 2017 and Dec 2, 2025 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Break” (15 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
- Break15
- Crack5
- Detachment of Device or Device Component1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions6
- No Code Available2
- No Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE CONV SHIM SZ5 18MM DEVICE WAS BROKEN POST SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23698452 ↗MalfunctionApr 5, 2024Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE ATTUNE INSTRUMENTS ARE BROKEN WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19049915 ↗MalfunctionApr 19, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT SHIM WAS CRACKED AND TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16769640 ↗MalfunctionApr 12, 2023Break; Break
IT WAS REPORTED THE INSTRUMENT ARE BROKEN. THERE IS NO DESCRIPTION OF HOW THE DAMAGE OCCURRED OR THE EXTENT OF THE DAMAGE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16728993 ↗MalfunctionAug 2, 2022Break; Break
IT WAS REPORTED THAT AN EMAIL RECEIVED FROM CSSD TECH WITH A LIST OF BROKEN INSTRUMENTS THAT HAVE BEEN COLLECTED IN CSSD. EMAIL CONTAINS ALL ITEMS FROM CONSIGNMENT SETS. NO INFORMATION IS PROVIDED AS TO HOW THEY BROKE, OR THE EXTENT OF DAMAGE THAT HAS BEEN INCURRED. ITEMS ONLY CONTAIN BATCH CODES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15145825 ↗MalfunctionDec 3, 2021Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
ATTUNE SHIM HAS CRACKED AROUND THE METAL INSERT AREA. ALSO ON TWO OF THE SHIMS THE METAL INSERT HAS STATED TO COME OUT OF SHIM BODY. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923769 ↗MalfunctionOct 30, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent
BROKEN AND WORN ATTUNE INSTRUMENTS.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10764462 ↗MalfunctionSep 17, 2020Break; Break
BROKEN INSTRUMENTS RETURNED TO THE WAREHOUSE. UNAWARE OF WHAT LED TO THE INSTRUMENTS BECOMING BROKEN.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10547217 ↗MalfunctionAug 24, 2020Break; Break
IT WAS REPORTED THAT WHILE EXTRACTING TRIAL POLY ( SHIM + ARTICULATING SURFACE ), THE SHIM BROKE AT THE BULLET CONNECTION SPOT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10442149 ↗MalfunctionJul 28, 2020Break; Break
BROKEN ATTUNE SHIMS, FEMORAL TRIAL AND PIN PULLER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10335887 ↗MalfunctionApr 17, 2020Break; Break
IT WAS REPORTED THAT THE CENTER PART OF SHIM WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9972759 ↗MalfunctionFeb 14, 2020Break; Break
TOTAL KNEE REPLACEMENT: BROKEN CONSIGNMENT INSTRUMENTS. INSTRUMENTS HAVE BEEN CONSIGNED SINCE 2014 AND HAVE BEEN BROKEN FROM PROLONGED USE. NO ADVERSE EFFECTS ON PATIENTS. NO DELAY IN THE PROCEDURE. THE BROKEN SHIM BROKE INTO MANY PIECES AND WAS DISCARDED AS IT WAS SHARP AND COVERED IN BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9710969 ↗MalfunctionDec 20, 2019Break; Break
IT WAS REPORTED THAT THE SPACER BLOCK, TWO SHIMS, AND LOBSTER CLAW, AND CUP IMPACTOR WERE BROKEN DURING WASH. THESE WERE NOT USED IN SURGERY AND SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9506310 ↗MalfunctionDec 4, 2019Break; Break
IT WAS REPORTED THAT THERE ARE SHARP EDGES ON ANTERIOR PART OF ARTIC SURF. THIS ITEM WAS NOT USED ON A PATIENT. THIS DID NOT DELAY SURGERY. NO ONE WAS INJURED. I AM RETURNING. SHIM IS CRACKED. THIS ITEM WAS NOT USED ON A PATIENT. THIS DID NOT DELAY SURGERY. NO ONE WAS INJURED. I AM RETURNING. FEMORAL IMPACTOR IS CRACKED. THIS ITEM WAS NOT USED ON A PATIENT. THIS DID NOT DELAY SURGERY. NO ONE WAS INJURED. I AM RETURNING. I AM RETURNING ALL ITEMS, THEY HAVE CRACKS BUT ARE STILL IN ONE PIECE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9412724 ↗MalfunctionFeb 12, 2019Break; Crack; Break; Crack
IT WAS REPORTED THAT STERILE PROCESSING ADVISED THAT A NUMBER OF SHIMS FROM ATTUNE SHIMS AND GENERAL TRAY WERE CRACKED AND BROKEN AND WOULD NOT BE ADEQUATELY AND SAFELY PROCESSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8331971 ↗MalfunctionJan 24, 2019Crack; Crack
STERILE PROCESSING ADVISED THAT A NUMBER OF SHIMS FROM ATTUNE'S SHIMS AND GENERAL TRAY WERE CRACKED AND BROKEN AND COULD NOT BE ADEQUATELY AND SAFELY PROCESSED. IT APPEARS SHIMS BROKE DURING THE WASH OR STERILIZER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8273928 ↗MalfunctionMay 18, 2018Crack; Crack
IT WAS REPORTED THAT THE SHIM HAS CRACKED AROUND THE METAL INSERT AREA. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7525148 ↗MalfunctionNov 17, 2017Break; Break
IT WAS REPORTED THAT FOUR ATTUNE SHIMS WERE BROKEN/DAMAGED.
Patient problems: No Information
MAUDE report 7042630 ↗
Other TEMPLATE devices
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- 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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