ATTUNE 2545-00-929Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 5 12mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune shim is a surgical template tool. The 41 reports mostly describe the shim breaking or cracking, often noticed during cleaning or handling rather than in patients, with no deaths or injuries mentioned. 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
- 41
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295135067), received between Sep 14, 2017 and Jun 1, 2026 — classified as 41 malfunctions.
The most frequently reported specific device problem is “Break” (30 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
- Break30
- Crack16
- Detachment of Device or Device Component2
- Component Missing1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient14
- Insufficient Information3
- No Information1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT THE SHIM DEVICES WERE BROKEN, THE ALIGNMENT ROD WAS BENT AND THE TRIAL POST DEVICES WERE CRACKED. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISCARDED. THERE WAS NO PATIENT OR USER HARM. THERE WERE NO REPORTS OF SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351296 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THERE WERE BROKEN TRIAL SHIMS, BENT ALIGNMENT ROD, CRACKED TRIAL POST.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25096069 ↗MalfunctionMar 25, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE SHIM WAS CRACKED AND THE SPACER BLOCK WAS MISSING SPRINGS ON THE PRONGS. IT WAS REPORTED THAT THE ISSUE DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690844 ↗MalfunctionNov 18, 2025Break; Break
IT WAS REPORTED THAT THE SHIM TRIALS WERE BROKEN DURING STERILIZATION PROCESS. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583402 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTED PRODUCTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437336 ↗MalfunctionJun 2, 2025Break; Break
IT WAS REPORTED THAT SIZE 5-6 12 MM SHIM BROKE IN HALF WHEN PICKING UP TO PUT ON THE DOG BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22124269 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21855795 ↗MalfunctionMar 18, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 21633720 ↗MalfunctionApr 25, 2024Break; Break
IT WAS REPORTED THAT THE SHIM BROKE INTO TWO PIECES, ALL PIECES RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19188630 ↗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 19158350 ↗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 18874702 ↗MalfunctionFeb 26, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT SHIM WAS CRACKED/BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, 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. 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 18778110 ↗MalfunctionDec 8, 2023Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT A TIBIAL TRAY WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18290618 ↗MalfunctionDec 7, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED FROM SALES REP: A. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? -NO. B. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18282033 ↗MalfunctionNov 6, 2023Crack; Crack
IT WAS REPORTED THAT THE ATTUNE SHIMS ARE CRACKED AND NEED TO BE REPLACED. THE EVENT DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION PROVIDED BY SALES REP STATES THAT THE SHIMS HAVE CRACKS IN THEM BUT THEY DID NOT BREAK INTO TWO OR MORE PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18072799 ↗MalfunctionJul 7, 2023Break; Break
IT WAS REPORTED THAT THE SHIM TRIALS WERE FOUND TO HAVE CRACKS IN THEM. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17277036 ↗MalfunctionMay 26, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DESCRIPTION OF THE DAMAGE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17009993 ↗MalfunctionApr 10, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY OR SURGERY THAT TOOK PLACE. THIS DER WAS COMPLETED IN RESPONSE TO THE HOSPITAL BEING PROACTIVE AND REALIZING THAT THE INSTRUMENTS THAT STAYED AT THE HOSPITAL WERE A SAFETY HAZARD TO PATIENTS HAVING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16710598 ↗MalfunctionMar 7, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16497034 ↗MalfunctionAug 25, 2022Break; Break
IT WAS REPORTED THAT THE 5/6 12MM SHIMS BROKE DURING SURGERY, BOTH BROKE RIGHT IN THE MIDDLE. BOTH WERE DISCARDED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299271 ↗MalfunctionAug 25, 2022Break; Break
IT WAS REPORTED THAT THE 5/6 12MM SHIMS BROKE DURING SURGERY, BOTH BROKE RIGHT IN THE MIDDLE. BOTH WERE DISCARDED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299230 ↗MalfunctionJun 22, 2022Crack; Crack
IT WAS REPORTED THAT WHEN STERILIZATION WAS PUTTING THE TRAYS BACK TOGETHER ON SATURDAY 4/30 NOTICED THAT SEVERAL OF THE MODULAR SHIMS HAD CRACKS IN THEM. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14776460 ↗MalfunctionMar 10, 2022Break; Break
IT WAS REPORTED THAT THE SIZE 5-6 X 12MM SHIM BROKE IN HALF WHILE TRIALING. BOTH PIECES WERE RETRIEVED. NO TIME LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13720911 ↗MalfunctionDec 20, 2021Break; Break
ATTUNE SHIM BROKEN NEEDS REPLACEMENT. NO REPORTED SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13043210 ↗MalfunctionJun 16, 2021Crack; Crack
IT WAS REPORTED THAT DURING POST CLEANING INSPECTION THE SHIM WAS FOUND TO BE CRACKED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12009652 ↗
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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