ATTUNE 2545-00-942Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 7 14mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295135197), received between Nov 9, 2017 and Oct 31, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Break” (14 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
- Break14
- Detachment of Device or Device Component3
- Crack2
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient7
- Insufficient Information1
- No Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435331 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435317 ↗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 20821680 ↗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 19049921 ↗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 18875074 ↗MalfunctionOct 20, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE SHIM BROKE INTO TWO PIECES AND NEEDS TO BE REPLACED. ALL PIECES WERE RETRIEVED. NO DELAY OR ADVERSE EVENT WAS EXPERIENCED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17977505 ↗MalfunctionApr 26, 2023Break; Break
IT WAS REPORTED THAT MULTIPLE SHIMS WERE DISCOVERED TO BE CRACKED AND NEED TO BE REMOVED AND REPLACED. ALL PIECES WERE RETRIEVED. NO TIME DELAY EXPERIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16815128 ↗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 12923708 ↗MalfunctionAug 5, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent
UNKNOWN SURGEON. BROKEN AND WORN ATTUNE INSTRUMENTS REPORTED BY (B)(6) POST SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10366843 ↗MalfunctionJul 28, 2020Break; Break
MalfunctionMar 12, 2020Break; Break
DURING A TOTAL KNEE TO REPLACEMENT AN ATTUNE IMPACTOR SHIM AND EXTRACTOR ALL SNAPPED DURING THE SURGERY. REPLACEMENTS WERE AVAILABLE AND ALL PIECES RETRIEVED NO PATIENTS CONSEQUENCES OR SURGICAL DELAY. IN ADDITION A SIGMA RP IMPACTOR IS NOTED TO HAVE DAMAGE ON THE BEARING SURFACE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9825246 ↗MalfunctionFeb 19, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
METAL INSERT OF ATTUNE SHIM 254500942 IS COMING OUT OF THE SHIM BODY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9728399 ↗MalfunctionMar 27, 2019Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN DURING USE AND NEEDED TO BE REPLACED. NO SURGICAL DELAY WAS CAUSED. ALL PIECES WERE RETRIEVED FROM PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8458173 ↗MalfunctionJul 10, 2018Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7674860 ↗MalfunctionJul 10, 2018Break; Break
IT WAS REPORTED THAT INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7673389 ↗MalfunctionNov 9, 2017Break; Break
IT WAS REPORTED THAT ATTUNE SHIMS CONTINUED TO CRACK AND BREAK APART. THEY KEPT ON SWITCHING TO OTHER SIZES TO MAKE IT WORK AND BROKE MANY.
Patient problems: No Information
MAUDE report 7014164 ↗
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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