ATTUNE 2545-00-941Recalls & reported problems
Depuy (Ireland) · ATTUNE CONVENTIONAL SHIM SIZE 7 12mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295135180), received between Apr 30, 2018 and Oct 31, 2025 — classified as 19 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break14
- Crack8
- Detachment of Device or Device Component1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient6
- Insufficient Information3
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438286 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437046 ↗MalfunctionAug 14, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE SURGERY, AND THE INSTRUMENTS WERE CRACKED/CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22806687 ↗MalfunctionJan 16, 2025Break; Break
IT WAS REPORTED THAT THE SHIM BROKE.
Patient problems: Insufficient Information
MAUDE report 21171353 ↗MalfunctionMay 30, 2024Break; Break
IT WAS REPORTED THAT THE SHIM BROKE OFF WHEN TRIALING.
Patient problems: Insufficient Information
MAUDE report 19423083 ↗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 18874383 ↗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 17277095 ↗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 16815127 ↗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 16663794 ↗MalfunctionJul 27, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAS BEEN BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12226583 ↗MalfunctionJun 7, 2021Crack; Crack
SHIMS ARE CRACKED. NO ASSOCIATED SURGICAL DELAYS OR PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11947256 ↗MalfunctionMar 15, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT ALL THE INSTRUMENTS ARE BROKEN THROUGH THE MAIN BODY. THE DRILL BITS ARE BENT OUT OF SHAPE AND ALL INSTRUMENTS REMAIN IN ONE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11486345 ↗MalfunctionMar 1, 2021Break; Crack; Break; Crack
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 11395860 ↗MalfunctionJul 28, 2020Break; Break
BROKEN ATTUNE SHIMS, FEMORAL TRIAL AND PIN PULLER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10335881 ↗MalfunctionDec 4, 2018Break; Break
IT WAS REPORTED THAT THE ATTUNE S7 7/8 12MM SHIM INSTRUMENT BROKE DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8128489 ↗MalfunctionOct 17, 2018Crack; Crack
IT WAS REPORTED THAT THE PLASTIC SHIMS CRACKED UPON TRIALING WITH THE INSERT TRIAL. ALL PIECES RECOVERED IMMEDIATELY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7973346 ↗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 7672992 ↗MalfunctionMay 15, 2018Crack; Crack
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 7515105 ↗MalfunctionApr 30, 2018Crack; Crack
IT WAS REPORTED THAT THE SHIMS HAVE 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 7472951 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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