ATTUNE 2545-00-743Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 5 7mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE 7mm shim, a sizing trial instrument used during hip replacement surgery, appears in 36 adverse event reports. Nearly all describe the plastic breaking, cracking, gouging or wearing out during use, and several note that nothing was left in the patient and no surgery was delayed. No deaths or injuries were reported, and 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295134152), received between Jun 30, 2017 and Apr 10, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Break” (31 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
- Break31
- Crack3
- Device-Device Incompatibility3
- Material Deformation2
- Naturally Worn2
- Scratched Material2
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- No Consequences Or Impact To Patient15
- Insufficient Information2
- No Code Available1
- No Information1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT A BIT OF PLASTIC BROKE OFF FROM THE SHIM TRIALS. THERE WERE NO DELAYS, AND NOTHING WAS LEFT IN THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844457 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437327 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427322 ↗MalfunctionOct 30, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427291 ↗MalfunctionJul 9, 2025Break; Break
IT WAS REPORTED THAT THERE WERE BROKEN INSTRUMENTS. THE SPRINGS WERE WORN BECAUSE THEY ARE FREQUENTLY USED TO OPEN THE DOG BONE AND BALANCED SIZER. NO PATIENT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22460150 ↗MalfunctionApr 17, 2025Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE TRIALS GOUGED/FLAKING.
Patient problems: Insufficient Information
MAUDE report 21854999 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED THAT THE PEGS WERE BROKEN AND/OR DAMAGED WITH SPRING DAMAGE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20856458 ↗MalfunctionDec 4, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, AND THE SURGEON BROKE THE DEVICE. SURGICAL DELAY AS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20843192 ↗MalfunctionSep 25, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: NO DELAY. NO ADVERSE CONSEQUENCES AFFECT THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20305921 ↗MalfunctionOct 18, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE IS CRACKED AND CHIPPED. 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 ONE. 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 17954641 ↗MalfunctionAug 30, 2023Break; Break
IT WAS REPORTED THAT SHIM WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17656119 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17597871 ↗MalfunctionJul 21, 2023Break; Break
IT WAS REPORTED THAT THE SHIM WAS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17370108 ↗MalfunctionJul 19, 2023Break; Naturally Worn; Break; Naturally Worn
DEVICE WAS FOUND BROKEN AND WITH AN OVERALL WORN APPEARANCE. NO REPORTED SURGICAL DELAYS OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17349634 ↗MalfunctionMay 30, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIM HAS SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17019095 ↗MalfunctionApr 3, 2023Break; Crack; Scratched Material; Break; Crack; Scratched Material
IT WAS REPORTED THAT THE DEVICE WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16663930 ↗MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BASE PLATE TRIAL BROKE INTO TWO PIECES. IT WAS DISPOSED OF BY STAFF AFTER THE CASE. THE SZ 7 SHIM WOULDN¿T ATTACH ONTO THE SPACER BLOCK. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15149395 ↗MalfunctionNov 29, 2021Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIM BROKE IN HALF WHEN EXTRACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12882980 ↗MalfunctionMar 1, 2021Break; Break
EMAIL RECEIVED FROM CSSD DEPARTMENT AT SJOG MURDOCH WITH THE BROKEN PRODUCTS THAT HAVE COME THROUGH CLEANING PROCESS. DESCRIPTIONS OF THE ACTUAL DAMAGE HAVE NOT BEEN PROVIDED AND WILL BE FOLLOWED UP. HOW THEY BROKE IS ALSO NOT DETAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11395848 ↗MalfunctionDec 8, 2020Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component
SPD NOTICED WHILE ASSEMBLING THE TRAY THAT THIS SHIM WAS HAD A CRACKED AND THE METAL RING WAS LOOSE. THE SHIM WAS CRACKED FROM THE CENTER TO THE METAL RING. THE METAL RING WAS STILL INTACT. ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10967974 ↗MalfunctionOct 15, 2020Break; Break
IT WAS REPORTED THAT THE ARTIC SURFACE AND SHIM BROKE INTO PIECES. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10684409 ↗MalfunctionOct 13, 2020Break; Break
IT WAS REPORTED THAT ATTUNE SHIM BROKE INTO TWO PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10673530 ↗MalfunctionOct 12, 2020Naturally Worn; Naturally Worn
MalfunctionMay 21, 2020Break; Break
IT WAS REPORTED THAT ATTUNE SPACER BLOCK CHIPPED ON THE END WHERE SPRINGS ARE, 5/6 (7MM) SHIM BROKE IN HALF, AND SIZE 4 FB ARTICULATING SURFACE CRACKED IN HALF. NO PATIENT INVOLVEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10081119 ↗MalfunctionMar 9, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THESE SHIMS CAME OUT OF THE WASHER WITH MINOR CHIPS AND WEAR. THEY DECIDED IT WAS BEST TO REPLACE. THIS WAS NOT AN INCIDENT THAT OCCURRED IN SURGERY. ALL PARTS WILL BE RETURNING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9805001 ↗
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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