ATTUNE 2545-00-673Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 7 8mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune shim is a sizing template used during joint replacement surgery. The 26 reports mostly describe shims breaking, cracking or becoming scratched and chipped, with no deaths and 1 injury 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
- 26
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295133551), received between Jun 28, 2017 and Oct 31, 2025 — classified as 1 injury, 25 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break18
- Material Integrity Problem4
- Scratched Material4
- Insufficient Device Problem Information1
- Material Deformation1
- Naturally Worn1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient5
- No Information2
Recent adverse event reports
The 25 most recent of 26 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 23438399 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438377 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE SHIMS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438324 ↗MalfunctionMay 3, 2024Break; Break
IT WAS REPORTED THAT THE SHIM TRIALS BROKE DURING REMOVAL, ALL PIECES RETRIEVED AND ACCOUNTED FOR, NO DELAYS TO SURGERY OR IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243435 ↗MalfunctionFeb 5, 2024Scratched Material; Scratched Material
SCRATCHED AND DAMAGED ATTUNE SHIM 8MM SIZE 7-8. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18645347 ↗MalfunctionDec 27, 2023Scratched Material; Scratched Material
IT WAS REPORTED THAT THE ATTUNE SHIM WAS CRACKED. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18404564 ↗MalfunctionNov 6, 2023Break; Scratched Material; Break; Scratched Material
ADDITIONAL INFORMATION FROM THE LOAN KIT TEAM: THE SHIM HAS A GOUGE OUT OF THE PLASTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18076185 ↗MalfunctionAug 22, 2023Break; Scratched Material; Break; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT HAD CHIPS AND SCRATCHES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17598283 ↗MalfunctionJun 30, 2023Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE SPACER FOR THE POLY IMPLANT WAS CHIPPED ON (B)(6) 2023 DURING REVISION SURGERY OF UNKNOWN TYPE. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR AN ATTUNE SHIM SZ7 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17238891 ↗MalfunctionJul 15, 2022Break; Break
IT WAS REPORTED THAT THE SHIM IS BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15027758 ↗MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem
ITEMS ARE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734227 ↗MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem
ITEMS ARE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734196 ↗MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem
ITEMS ARE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734112 ↗MalfunctionJun 17, 2022Material Integrity Problem; Material Integrity Problem
ITEMS ARE DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14734091 ↗MalfunctionDec 30, 2021Break; Break
IT WAS REPORTED THAT DURING TRIALING OF THE KNEE, THE SHIM AND ARTICULAR SURFACE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13118240 ↗MalfunctionNov 23, 2021Break; Break
INSERT AND SHIM BROKE UPON REMOVAL AND AFTER TRIALLING WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861500 ↗MalfunctionNov 23, 2021Break; Break
INSERT AND SHIM BROKE UPON REMOVAL AND AFTER TRIALLING WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12861499 ↗MalfunctionSep 21, 2021Break; Break
SURGEON TRIED TO PUSH OUR ATTUNE TRIAL IN A VERY TIGHT SPACE AND THE CONNECTOR BROKE WITHIN THE SHIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12508723 ↗MalfunctionJun 11, 2021Break; Break
IT WAS REPORTED THAT AN ATTUNE SHIM HAS A DEEP CHIP AND PROCESSING SAYS IT MUST BE REPLACED DUE TO STERILITY CONCERNS. DO NOT KNOW HOW DAMAGE OCCURRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11984298 ↗MalfunctionOct 23, 2020Break; Break
IT WAS REPORTED THAT AS THE DOCTOR WAS TRIALING THE 7X8 PS INSERT TRIAL, THE SPACER AND THE ARTICULATING SURFACE BOTH CRACKED AND BROKE. THE ARTICULATING SERVICE JUST CRACKED AND THE SPACER BROKE IN HALF. BOTH PIECES WERE RETRIEVED. NOR PIECES WERE LEFT IN THE PATIENT. THE SURGERY WAS NOT DELAYED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10727076 ↗MalfunctionMar 26, 2020Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE, SHIM AND TRIAL EXTRACTOR WERE ALL BROKEN OR DAMAGED WHILE TRYING TO REMOVE THE TRIAL SPACER. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9884823 ↗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 8897290 ↗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 7908435 ↗MalfunctionJan 26, 2018Break; Break
IT WAS REPORTED THAT BROKE TRIALS IN SET THAT NEED TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7221192 ↗MalfunctionSep 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TRIAL WAS FOUND BROKEN AFTER PROCESSING.
Patient problems: No Information
MAUDE report 6904091 ↗
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 13, 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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