ATTUNE 2545-00-523Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE FIXED BEARING CRUCIATE RETAINING SIZE 3 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE fixed-bearing knee implant is used in total knee replacement surgery. Most of the 31 reports describe trial instruments and parts breaking or coming apart during surgery — springs detaching or going missing, sometimes found before the operation — with no injuries and no deaths reported. One recall, started in June 2015 and closed, concerned a small wire spring that could break loose from the trial instruments and enter the surgical site.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295132639), received between Nov 7, 2017 and Aug 26, 2026 — classified as 31 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jun 12, 2015Class IITerminated
Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Z-2138-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component18
- Break16
- Component Missing3
- Material Deformation2
- Device Damaged Prior to Use1
- Device-Device Incompatibility1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient7
- No Information1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Break
It was reported that Attune trials were broken and that pulled from pans buildup had generated multiple codes. Dates for each code breaking were not available. Notification was made in the morning. There were no adverse consequences that affected the patient due to the reported event. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453817 ↗MalfunctionJun 5, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE A COUPLE OF LOST SPRINGS FROM ARTICULATING SURFACES IN AN ATTUNE KIT DURING SURGERIES. IT WAS ALSO NOTED THAT THE IM REAMER HAD A NOT SHARP TIP. NO IMPACT ON PATIENT HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414323 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT DURING INSPECTION OF A KIT BEFORE SURGERY THAT THERE WAS A BROKEN SPRING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411581 ↗MalfunctionFeb 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY SURGERY THE POLY TRIAL SPRING WAS MISSING AND THE PATELLA CLAMP BUTTON ATTACHMENT WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24333756 ↗MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE INSTRUMENTS WERE MISSING SPRINGS, AND EASILY DISPLACED FROM THE ARCTIC SURFS. BROKEN INSTRUMENTS, HAPPENED DURING SURGERY BUT NO PATIENT AFFECTED, OR SURGERY DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23495934 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS SPANNED OFF OF THE ATTUNE ARTICULATION SURFACE FIXED BEARING CRUCIATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23489849 ↗MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS FELL OFF IN COUPLE OF PROCEDURES. (B)(4), IS RELATED TO (B)(4), AND (B)(4). (B)(4), IS THE MOTHER COMPLAINT. (B)(4), AND (B)(4), WERE CREATED TO CAPTURE THE ADDITIONAL IPS OF THE MOTHER COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486024 ↗MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WAS LOOSE SPRING ON ATTUNE ARTICULATING SURFACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22849010 ↗MalfunctionJul 30, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED DURING THE PROCEDURE, THE METAL SPRINGS FROM THE UNDERSIDE OF THE ARTICULATING SURFACE HAVE BECOME DETACHED/FALLEN OFF. THE SPRINGS ARE MISSHAPEN AND STRETCHED AND SO CANNOT BE REATTACHED SECURELY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22663930 ↗MalfunctionJul 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE MULTIPLE CR ARTIC SURFACES WHERE THE SPRINGS HAVE BROKEN OFF AND ARE NOW MISSING. THIS OCCURRED DURING THE TIME OF THE PROCEDURE. THEY WERE REMOVED FROM THE SET. THERE WERE NO PATIENT CONSEQUENCE. PRODUCT NAME: ATTUNE FB CR ARTIC SURF. PRODUCT CODE: 254500523/ 254500526/ 254500527/ 254500528. SIZE 3(254500523) X2. SIZE 6(254500526) X2. SIZE 7 (254500527X1. SIZE 8 (254500528) X1. SET CODE: LKATTC003CN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385223 ↗MalfunctionJul 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THERE WERE MULTIPLE CR ARTIC SURFACES WHERE THE SPRINGS HAVE BROKEN OFF AND ARE NOW MISSING. THIS OCCURRED DURING THE TIME OF THE PROCEDURE. THEY WERE REMOVED FROM THE SET. THERE WERE NO PATIENT CONSEQUENCE. PRODUCT NAME: ATTUNE FB CR ARTIC SURF PRODUCT CODE: 254500523/ 254500526/ 254500527/ 254500528. SIZE 3(254500523) X2. SIZE 6(254500526) X2. SIZE 7 (254500527X1. SIZE 8 (254500528) X1. SET CODE: LKATTC003CN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384911 ↗MalfunctionMar 11, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEM WAS BROKEN, NO LONGER ABLE TO CONNECT THE SHIMS DUE TO MISSING SPRINGS (MISSING DURING STERILISATION). THERE WAS NO DELAY TO SURGERY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21574050 ↗MalfunctionNov 27, 2023Break; Break
IT WAS REPORTED THAT THE SPRING ON THE ARTIC SURFACE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208823 ↗MalfunctionJun 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED FROM THE UNITED KINGDOM THAT BEFORE SURGERY STARTED IT WAS OBSERVED THAT THE BALSEAL RINGS ON THE ATTUNE ARTICULATING SURFACES WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17181870 ↗MalfunctionMay 3, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE INSTRUMENT WAS BROKEN OFF BUT IT DID NOT OCCUR DURING SURGERY SO IT WAS NOT RETRIEVED FROM A PATIENT RATHER IT HAPPENED DURING STERILIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16863755 ↗MalfunctionMay 3, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING FELL OFF OF BOTH OF THE POLY TRIALS. BOTTOM SPRING CONNECTED ON THE TWO LEGS ON THE BOTTOM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16863620 ↗MalfunctionApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE INCIDENT HAPPENED DURING CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16823750 ↗MalfunctionApr 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRING DETACHED ON THE TRIAL. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16726511 ↗MalfunctionApr 3, 2023Break; Break
IT WAS REPORTED THE INSTRUMENTS ARE BROKEN. NO DETAILS ON HOW INSTRUMENTS WERE BROKEN OR EXTENT OF DAMAGE AVAILABLE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16664227 ↗MalfunctionFeb 21, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE SPRINGS CAME LOOSE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16411550 ↗MalfunctionFeb 21, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE SHIM HAS LOST ITS SPRING AND CAN NOT BE USED ON THE PLATFORMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16409056 ↗MalfunctionOct 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING AT THE BACK OF BOTH INSTRUMENTS IS DAMAGED DURING THE PROCEDURE. NO PATIENT HARM. NO DELAYS. NO X-RAYS TAKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15631342 ↗MalfunctionFeb 22, 2022Break; Break
ADDITIONAL INFORMATION RECEIVED INDICATED THAT ALL PIECES IF THE BROKEN INSTRUMENT WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13578620 ↗MalfunctionAug 13, 2019Break; Break
SMALL BAL SEAL RETAINING POST HAS SNAPPED OFF. PLEASE SEE ATTACHED. NOTE SNAPPED OFF RETAINING POST WAS NOT RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8889568 ↗MalfunctionDec 20, 2018Break; Break
IT WAS REPORTED THAT PRIOR TO SURGERY, SCRUB TECH WAS INSPECTING THE INSTRUMENT TRAYS AND NOTICED THE ARTICULATING SURFACE SIZE 3 FB WAS BROKEN. THE SPRING CONNECTING THE ARTICULATING SURFACE TO THE SHIM WAS MISSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8184460 ↗
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- 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 · each recall links to the FDA recall notice
- 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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