ATTUNE 2545-00-979Recalls & reported problems
Depuy (Ireland) · ATTUNE FB PS ARTICULATION SURFACE SIZE 9 · 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
- 1
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295135562), received between Jun 7, 2016 and Sep 2, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Break” (15 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 16, 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-2142-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break15
- Material Deformation3
- Detachment of Device or Device Component2
- Crack1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions6
- No Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Material Deformation; Scratched Material; Material Deformation; Scratched Material
DATE J&J BECAME AWARE: 14.7.25. DATE OF EVENT: 12.7.24. PRODUCT NAME: ATTUNE ARTICULATE SURFACE SIZE 9 FB . PRODUCT CODE: 254500979. LOT NUMBER: BFA0V5Y. DESCRIPTION OF DAMAGE SPRING IS LOOSE AND DAMAGE PLASTIC. EVENT OCCURRED DURING A PROCEDURE. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE OR ADVERSE OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936227 ↗MalfunctionJul 17, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THERE ARE SEVERAL ARTICULATING SURFACE COMPONENTS THAT HAVE PRONGS BENT, OR WARPED, AND SPRINGS MISSING. THIS DID NOT CAUSE A DELAY, AND NO ONE WAS INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17334335 ↗MalfunctionJul 17, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THERE ARE SEVERAL ARTICULATING SURFACE COMPONENTS THAT HAVE PRONGS BENT, OR WARPED, AND SPRINGS MISSING. THIS DID NOT CAUSE A DELAY, AND NO ONE WAS INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17334307 ↗MalfunctionFeb 22, 2023Break; Break
IT WAS REPORTED THAT THE SURGEON HIT TRIAL WITH A MALLET AND THE SIDE OF SURFACE BROKE OFF. ALL PARTS RETRIEVED. IT WAS UNKNOWN ABOUT THE SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16419188 ↗MalfunctionApr 1, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WAS BROKEN OR NOT IN USABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13977020 ↗MalfunctionDec 23, 2021Break; Break
BOTTOM PEG IS SHEERED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13076817 ↗MalfunctionSep 21, 2020Break; Break
IT WAS REPORTED THAT THE INSERT TRIAL WAS BROKEN DURING PROCEDURE. ALL PIECES GATHERED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10563585 ↗MalfunctionJul 16, 2020Break; Break
IT WAS REPORTED THAT WHILE REMOVING THE INSERT TRIAL, THE PLASTIC INSTRUMENT SNAPPED IN TWO. ALL PARTS WERE RETRIEVED. NOTHING LEFT IN PATIENT. THE INSERT TRIAL INSTRUMENT WAS THROWN IN TRASH. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10281254 ↗MalfunctionDec 28, 2018Crack; Crack
IT WAS REPORTED THAT THE SIZE 9 FB PS INSERT ARTICULATE SURFACE WAS BEING TRIALED AND WHEN TAKEN, IT CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8202439 ↗MalfunctionDec 26, 2018Break; Break
INSERTS BROKE DURING TRIAL REDUCTION. PATIENT CONSEQUENCE?: NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8196832 ↗MalfunctionNov 2, 2018Break; Break
IT WAS REPORTED THAT THE PEG ON ATTUNE TRIALS BROKE DURING INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8033608 ↗MalfunctionNov 2, 2018Break; Break
IT WAS REPORTED THAT THE PEG ON ATTUNE TRIALS BROKE DURING INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8033557 ↗MalfunctionJun 11, 2018Break; Break
IT WAS REPORTED THAT THE POLY TRIAL BROKE AT INSERTION WHILE CEMENTING. NO SURGICAL DELAY. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7586482 ↗MalfunctionJun 11, 2018Break; Break
IT WAS REPORTED THAT INSTRUMENT WAS FOUND TO BE DAMAGED/ BROKEN PRIOR TO THE PROCEDURE- ALL BROKEN PARTS WERE RETRIEVED FROM THE FIELD PRIOR TO INCISION. SURGERY TIME WAS NOT DELAYED DUE TO THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7586312 ↗MalfunctionMay 31, 2018Break; Break
IT WAS REPORTED THAT ATTUNE POLY TRIAL HAS A BROKEN PEG FROM DOCTOR EXTRACTING IT FROM THE TRAIL. ALL PIECES RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7556299 ↗MalfunctionJan 10, 2018Break; Break
TOTAL KNEE REPLACEMENT - DR. (B)(6), (B)(6) ON (B)(6) 2017. WHILE PERFORMING A TOTAL KNEE REPLACEMENT, IT WAS NOTICED THAT THERE WAS DAMAGE TO AN ATTUNE ARTICULATING SURFACE AS WELL AS 2 ATTUNE SHIMS. THIS DAMAGE INCLUDES A SILVER O RING BROKEN FROM A SHIM AND STUCK TO THE ARTICULATING SURFACE AS EVIDENCED BY PHOTOS ATTACHED TO THIS EMAIL. THE ADDITIONAL SHIM HAS A SMALL CRACK IN IT. THESE WERE NOTICED BEFORE BEING USED ON THE PATIENT. NO DELAY OR ADVERSE RESULT WAS REPORTED. (B)(6). NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7178108 ↗MalfunctionNov 16, 2017Break; Break
IT WAS REPORTED THAT THE TRIALS BROKE WHILE TRIALING.
Patient problems: No Information
MAUDE report 7036915 ↗MalfunctionAug 15, 2017Break; Break
IT WAS REPORTED THAT THE MACRO TRIAL HAD A SPRING COME OFF AFTER TRAILLING. IT WAS STATED THAT THE X-RAY CONFIRMED THAT THE SPRING WAS NOT ON PATIENTS KNEE.
Patient problems: No Information
MAUDE report 6794619 ↗MalfunctionJun 7, 2016Break; Break
THE ARTICULAR SURFACE TRIAL BROKE IN TWO PIECES WHEN REMOVING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5702754 ↗
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 · each recall links to the FDA recall notice
- 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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