ATTUNE 2545-00-632Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 3 6mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295133346), received between Aug 3, 2018 and Oct 30, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
- Break18
- Crack3
- Material Deformation1
- Peeled/Delaminated1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient7
- Insufficient Information1
- Not Applicable1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THERE WERE TWO DAMAGED SHIMS. THE SHIMS ARE WORN AND NEED REPLACING, CONCERN AROUND PLASTIC FRAGMENTS COMING OFF THE SHIM. THERE WAS NO PATIENT INVOLVEMENT. SHIMS: SZ 3-4 6MM. SZ 5-6 6MM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425805 ↗MalfunctionAug 14, 2025Break; Break
IT WAS REPORTED THAT THE SHIM BROKE WHEN THE TECH WAS TRYING TO TAKE IT APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22805961 ↗MalfunctionApr 29, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING A PROCEDURE, THE SHIM CRACKED AND SPLIT INTO TWO PIECES. A SECOND INSTRUMENT FROM ANOTHER SET WAS USED. THE SURGERY WAS NOT PROLONGED, AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927209 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE SHIM BROKE IN HALF WHILE TRIALING.
Patient problems: Insufficient Information
MAUDE report 20407746 ↗MalfunctionJul 1, 2024Break; Break
THIS INSTRUMENT BROKE WHILE BEING USED DURING A SURGERY. IT BROKE IN CLEAN PIECES AND ALL BROKEN PIECES WERE RECOVERED. NO SIGNIFICANT DELAYS OCCURRED AND THERE WAS NO ADVERSE IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19644263 ↗MalfunctionJan 11, 2024Break; Break
ATTUNE SHIM SZ3 6MM IS CHIPPED AT THE INNER EDGE. 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, (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 18498404 ↗MalfunctionNov 15, 2023Break; Break
IT WAS REPORTED THAT THE 3/4 6MM SHIM BROKE INTO PIECES. THERE WERE NO PIECES LEFT IN PATIENT. UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18144709 ↗MalfunctionSep 27, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SHIM IS CRACKED/BROKEN 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. 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 17824708 ↗MalfunctionSep 22, 2023Break; Break
IT WAS REPORTED THAT SMALL PIECES BROKE OFF THE SHIM DURING CLEANING PROCESS. SURGERY TIME WAS NOT EXTENDED AS A DIRECT RESULT OF INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17798179 ↗MalfunctionApr 21, 2023Break; Break
IT WAS REPORTED THAT THE SHIM BROKE IN HALF ON THE BACK TABLE AFTER THE CASE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16792438 ↗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 16728968 ↗MalfunctionJan 17, 2022Break; Crack; Break; Crack
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN. NO DETAILS AS TO HOW THE DAMAGE OCCURRED OR THE EXTENT OF THE DAMAGE IS PROVIDED ONLY THE ITEMS CODES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13266115 ↗MalfunctionJul 1, 2020Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ATTUNE SHIM SZ3 6MM WAS BROKEN IN HALF AND SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10216378 ↗MalfunctionAug 15, 2019Break; Material Deformation; Break; Material Deformation
VARIOUS ATTUNE SHIMS FROM THE "SHIMS AND GENERAL INSTRUMENT" TRAY ARE SHOWING SIGNS OF WEAR, IN PARTICULAR CHIPPING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8897286 ↗MalfunctionMar 21, 2019Break; Break
PLASTIC CRACKS OR BREAKS APART AS PREVIOUS INCIDENCES. EVENT DATE (B)(6) OR (B)(6) 2019.
Patient problems: Not Applicable
MAUDE report 8440513 ↗MalfunctionMar 19, 2019Break; Break
PLASTIC CRACKS OR BREAKS APART FOR DEVICE. EVENT DATE: (B)(6) OR (B)(6) 2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8432232 ↗MalfunctionFeb 21, 2019Break; Break
BROKEN INSTRUMENTS IN CONSIGNMENT TRAYS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8357370 ↗MalfunctionNov 2, 2018Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS CHIPPED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8032288 ↗MalfunctionSep 25, 2018Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT ATTUNE SHIMS CHIPPED AND DAMAGED FROM RETRACTORS IN SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7908400 ↗MalfunctionAug 3, 2018Scratched Material; Scratched Material
IT WAS REPORTED THAT ATTUNE SHIMS CRACKED. FOUND DURING REP INSPECTION AND NOT DURING SURGERY. NO FURTHER INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7746365 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page