ATTUNE 2545-00-975Recalls & reported problems
Depuy (Ireland) · ATTUNE CONV FB PS ARTICULATION SURFACE SIZE 5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy ATTUNE trial insert used to test knee implant fit during surgery. The 48 reports mostly describe parts cracking or breaking before or during surgery, bent or twisted metal, and small components such as a wire spring ring coming off or going missing; one report involved an injury. There were no deaths, and one recall, started in June 2015 and closed, because that small spring ring could come off 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
- 48
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295135524), received between Jul 7, 2017 and Jun 6, 2025 — classified as 1 injury, 47 malfunctions.
The most frequently reported specific device problem is “Break” (38 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
- Break38
- Material Twisted/Bent5
- Component Missing4
- Crack3
- Detachment of Device or Device Component2
- Naturally Worn2
- Material Deformation1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient30
- No Clinical Signs, Symptoms or Conditions12
- No Information3
- Not Applicable2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2025Break; Break
IT WAS NOTICED THAT THERE WAS A SMALL CHIP MISSING FOR AN ARTICULAR SURFACE BEFORE THE SURGERY STARTED. IT WAS NEEDED DURING THE SURGERY. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157995 ↗MalfunctionJul 25, 2024Break; Break
IT WAS REPORTED THAT THERE WAS HOLE IN POLY.
Patient problems: Insufficient Information
MAUDE report 19825740 ↗MalfunctionJun 21, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT THE PRONG WAS BENT AND DAMAGED. THE SPRING WAS MISSING AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17172879 ↗MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ATTUNE ARTICULATING SURFACE WHERE THE BALSEAL RING HAS BEEN LOST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643946 ↗MalfunctionFeb 13, 2023Break; Break
IT WAS REPORTED THAT THE ARTICULATING TRIAL CRACKED IN HALF WHEN TRIED TO EXPLANT IT. IT BROKE IN ONLY TWO PIECES DOWN THE LEFT SIDE. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16364571 ↗MalfunctionFeb 8, 2023Break; Break
IT WAS REPORTED THAT TRIAL IS BROKEN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16322616 ↗MalfunctionFeb 8, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL IS BROKEN. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16322241 ↗MalfunctionFeb 22, 2022Crack; Crack
IT WAS REPORTED THAT THE BEARING SURFACE CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13576438 ↗MalfunctionSep 2, 2021Break; Break
IT WAS REPORTED THAT THE ATTUNE SIZE 5 PS FB ARTIC SURF WAS BROKEN BY THE SURGEON DURING TRIAL REMOVAL. THE AFFECTED PORTION IS THE BACK LEFT CORNER. ALL PIECES WERE REMOVED FROM THE STERILE FIELD. SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12416044 ↗MalfunctionApr 15, 2021Break; Break
DURING A TOTAL KNEE ARTHROPLASTY, SURGEON WAS ATTEMPTING TO INSERT HIS SZ 5 FB TRIAL POLY INTO THE JOINT SPACE. AFTER IS FIRST UNSUCCESSFUL ATTEMPT DR. DECIDED TO USE THE HANDLE OF A MALLET, TO AID IN GETTING THE TRIAL BEARING TO SEAT. UNFORTUNATELY, THE METAL MALLET IS MUCH HARDER THEN A PLASTIC POLY TRIAL AND THE TRIAL BROKE. SURGERY DELAYED 1 MINUTE REMOVED BROKEN POLY TRIAL AND INSERTED ANOTHER POLY TRIAL, PROCEDURE SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11671446 ↗MalfunctionFeb 3, 2021Use of Device Problem; Material Twisted/Bent; Use of Device Problem; Material Twisted/Bent
IT WAS REPORTED BROKEN, WORN DOWN TRIALS AND MISSING BEARINGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11275640 ↗MalfunctionJan 29, 2021Break; Break
IT WAS REPORTED THAT THE ATTUNE SZ 5 FB ARTICULATING SURFACE BROKE IN HALF DOWN THE MIDDLE WHEN THE SURGEON WAS REMOVING FROM THE JOINT. NO PATIENT INVOLVEMENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11251004 ↗MalfunctionJan 5, 2021Break; Break
TRIAL FB PS TIBIAL INSERT BROKE IN 2 WHILE REMOVING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11118638 ↗MalfunctionOct 23, 2020Break; Break
IT WAS REPORTED THAT THE FEMORAL IMPACTOR WAS BROKEN WHILE IMPLANTING FEMUR, AND ARTICULAR SURFACE WAS BROKEN WHILE TRYING TO REMOVE IT WHEN TRYING. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10729975 ↗MalfunctionOct 16, 2020Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PS INSERT TRIAL FOUND WITH HOLE WORN INTO PLASTIC PIECE WAS NOT USED DURING PROCEDURE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10689463 ↗MalfunctionAug 31, 2020Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE BROKE WHILE REMOVING TRIAL INSERT. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10474430 ↗MalfunctionJul 22, 2020Break; Component Missing; Material Twisted/Bent; Naturally Worn; Break; Component Missing; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THEY HAVE SEVERAL ITEMS THAT THE CENTRAL STERILE DEPARTMENT WANTS REPLACED, DUE TO BROKEN PIECES. I HAVE 2 ARTIC SURF PIECES MISSING SPRINGS. I HAVE 1 ARTIC SURF MISSING AN ENTIRE PRONG, THEY DO NOT HAVE MISSING PRONG, THERE WAS JUST A HOLE WHERE IT USED TO BE. THEY HAVE IMPACTION HANDLE THAT THE RED TRIGGERS AS BROKEN OFF, THEY HAVE ALL 3 PIECES, HANDPIECE, TRIGGER, AND SPRING. NONE OF THESE ITEMS WERE BROKEN IN SURGERY, NONE OF THESE ITEMS DELAYED A SURGERY, NO ONE WAS INJURED BY THESE ITEMS. THEY ARE BROKEN, MISSING PIECES FROM NORMAL WEAR AND TEAR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10309860 ↗MalfunctionApr 8, 2020Break; Break
IT WAS REPORTED THAT THE TRIAL BROKE IN 2 PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9934511 ↗MalfunctionJan 29, 2020Component Missing; Material Twisted/Bent; Scratched Material; Component Missing; Material Twisted/Bent; Scratched Material
DURING REPROCESSING, THE STERILIZATION TECHNICIAN FOUND THAT ONE OF THE BALSEAL SPRINGS ON AN ATTUNE SIZE 5 TRIAL ARTICULATING SURFACE WAS BENT. THE TECHNICIAN ALSO FOUND THERE TO BE DEEP SCRATCHES ON THE FRONT SURFACE OF THE TRIAL. WHEN I WAS GIVEN THE ITEM, THE ONE OF THE 2 BALSEAL SPRINGS WAS MISSING. IT IS NOT AVAILABLE FOR RETURN. AS FAR AS I HAVE BEEN TOLD, THE SPRING WAS DISPOSED OF. THERE WAS NO PATIENT CONSEQUENCE TO MY KNOWLEDGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9643807 ↗MalfunctionJan 17, 2020Break; Break
IT WAS REPORTED THAT THE ATTUNE ARTICULAR SURFACE BEARING POST WAS BROKE OFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9603626 ↗MalfunctionJan 9, 2020Break; Break
IT WAS REPORTED THAT THE SIZE 5 FB ARTICULATING SURFACE WAS BROKEN. ALL BROKEN PARTS WERE ACCOUNTED FOR. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9570818 ↗MalfunctionNov 1, 2019Break; Break
IT WAS REPORTED THAT AFTER THE CASE, WHILE TAKING SHIMS OFF OF INSERT TRIALS, THE TRIAL WAS BROKEN. THE BROKEN PIECE WAS THROWN AWAY BUT THE INSERT WAS BEING RETURNED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9267639 ↗MalfunctionOct 31, 2019Component Missing; Component Missing
UPON INSPECTION NOTICED THE SPRING MISSING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9262306 ↗MalfunctionOct 11, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT SPRING OF THE ATTUNE CONV FB PS TB TRL SZ5 WAS BROKEN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9179717 ↗MalfunctionOct 3, 2019Component Missing; Component Missing
SPRING CAME OFF OF AN INSTRUMENT AND WAS LOST IN THEATRE. STAFF REPORT THAT THE INSTRUMENTS WERE CHECKED AT THE BEGINNING OF THE SURGERY AND ALL WAS OK. X-RAY WAS USED TO TRY AND LOCATE THE SPRING. NOT IDENTIFIED ON X-RAY AND NOT FOUND IN THEATRE. NOT RESOLVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9150517 ↗
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- 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 · 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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