ATTUNE 2545-00-671Recalls & reported problems
Depuy (Ireland) · ATTUNE SHIM SIZE 7 5mm · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune shim, a thin trial piece used during knee replacement surgery, has 117 adverse event reports on file. Most describe the shim breaking, cracking or wearing down, and many say no patient was affected. The reports include no deaths or injuries, and the number of reports fell from 9 to 3 over the last 12 months. 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
- 118
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10603295133537), received between Jul 12, 2017 and Sep 29, 2026 — classified as 118 malfunctions.
The most frequently reported specific device problem is “Break” (103 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
- Break103
- Crack10
- Material Integrity Problem6
- Naturally Worn3
- No Apparent Adverse Event3
- Scratched Material3
- Appropriate Device Problem Term/Code Not Available1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions68
- No Consequences Or Impact To Patient37
- No Information11
- Insufficient Information2
- Not Applicable2
Recent adverse event reports
The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937453 ↗MalfunctionJul 28, 2026Appropriate Device Problem Term/Code Not Available
It was reported that during this case, while trailing, both size 7 PS RP trials, the size 5/6 5mm and the size 7/8 5mm shims all broke. There was no harm to patient or delay and all pieces of the broken trial were found.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063176 ↗MalfunctionMar 17, 2026Break
ITEM ISSUES FOUND DURING ROUTINE TRAY INSPECTION. SHIM BROKEN IN TWO PIECES. UPROD NO LONGER FUNCTIONS AS DESIGNED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619955 ↗MalfunctionNov 24, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE SHIM IS DAMAGED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631323 ↗MalfunctionOct 28, 2025Break; Break
IT WAS REPORTED THAT THE SHIM BROKE INTO 2 PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403196 ↗MalfunctionSep 12, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL SHIM BROKE IN HALF WHEN THE SURGEON TRIED TO REMOVE IT FOR FINAL IMPLANT. THERE WAS NO DELAY IN SURGERY AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037025 ↗MalfunctionSep 11, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT POSTOPERATIVELY, IT WAS NOTICED THAT A SHIM SIZE 7-8 5MM WAS BROKEN AND WORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23027150 ↗MalfunctionMar 24, 2025Break; Break
IT WAS REPORTED THAT THE SHIM AND TRAY WERE ATTACHED TO EACH OTHER DURING THE TRIALING STEP. WHEN REMOVING THE 2 TOGETHER THE SHIM SNAPPED OFF THE TRAY BRINGING THE PEG AND SPRING FROM THE TRAY WITH IT. ALL BROKER PIECES HAVE BEEN RETRIEVED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21678236 ↗MalfunctionFeb 24, 2025No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445300 ↗MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT A SHIM TRIAL BROKEN INTO 2 PIECES. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21305351 ↗MalfunctionJan 6, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT ALL PIECES OF THE BROKEN INSTRUMENT WERE RETRIEVED FROM THE PATIENT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21081412 ↗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 20855844 ↗MalfunctionNov 14, 2024Break; Break
IT WAS REPORTED THAT THE SPRING ON THE BOTTOM OF THE ATTUNE SIZE 7 RP TRIAL BROKE OFF. THE 5MM SHIM SNAPPED IN HALF. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20686014 ↗MalfunctionOct 21, 2024Break; Break
IT WAS REPORTED THAT THE SHIM IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495089 ↗MalfunctionOct 8, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20402074 ↗MalfunctionJul 31, 2024Break; Break
IT WAS REPORTED THAT THE SHIM BROKE DURING EXTRACTION. ALL PIECES RETRIEVED. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19873198 ↗MalfunctionJul 8, 2024Break; Break
IT WAS REPORTED THAT THE 5MM SHIM BROKE IN HALF. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19690114 ↗MalfunctionMay 23, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE INSTRUMENT WAS REPORTED FOR AN UNKNOWN REASON. DID NOT HAPPEN IN SURGERY. ADDITIONAL EVENT INFORMATION: VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED THAT THE ATTUNE SHIM SZ7 5MM WAS FOUND BROKEN IN HALF WHICH WILL BE CAPTURED WITHIN THE PRODUCT INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387523 ↗MalfunctionMay 14, 2024Break; Break
IT WAS REPORTED THAT ITEM BROKE IN HALF. THERE WAS NO SURGICAL DELAY. ALL PIECES RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19309098 ↗MalfunctionApr 9, 2024Break; Break
IT WAS REPORTED THAT THE SHIM BROKE. 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 19075799 ↗MalfunctionMar 5, 2024Scratched Material; Scratched Material
IT WAS REPORTED THAT ITEMS HAVE GOUGES. 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 18837372 ↗MalfunctionNov 30, 2023Break; Crack; Break; Crack
ADDITIONAL INFORMATION FROM THE SALES REP STATES THAT THE SHIMS WERE DAMAGED. ONE HAD A CRACK IN IT. THE OTHER A CHIP OUT OF IT. PHOTOS WERE UPLOADED OF THE SHIMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243565 ↗MalfunctionNov 30, 2023Break; Break
ATTUNE SHIM SNAPPED IN TWO. PATIENT NOT AFFECTED, SURGERY TIME NOT AFFECTED AND ALL PARTS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18243179 ↗MalfunctionNov 30, 2023Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> NONE, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IF YES, DESCRIBE --> NONE, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01898741 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 18237662 ↗MalfunctionNov 16, 2023Break; Scratched Material; Break; Scratched Material
THE PRODUCT HAS A FEW SPOTS ON IT WHERE THE PLASTIC HAS CHIPPED AWAY FROM THE EDGES. 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 18155051 ↗
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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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