ATTUNE 2545-00-978Recalls & reported problems
Depuy (Ireland) · ATTUNE CONV FB PS ARTICULATION SURFACE SIZE 8 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune knee trial insert is a reusable instrument used to test fit during knee replacement surgery. The 24 reports mostly describe the insert breaking during trialing or sterilization, sometimes into pieces that were retrieved, with no deaths and no injuries mentioned. It has 1 closed recall started in June 2015 about a small spring coil that 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295135555), received between Oct 19, 2017 and Aug 13, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (21 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-2142-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break21
- Component Missing1
- Crack1
- Detachment of Device or Device Component1
- Material Deformation1
- Material Twisted/Bent1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient12
- No Clinical Signs, Symptoms or Conditions9
- No Information3
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797186 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE ARTICULATING SURFACE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797181 ↗MalfunctionApr 4, 2023Break; Break
IT WAS REPORTED THAT THE TRIAL INSERT BROKE WHILE TRIALING. IT BROKE INTO TWO PIECES. ALL PIECES WERE RETRIEVED FROM THE KNEE. THIS DID NOT ADD ANYMORE TIME TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16673726 ↗MalfunctionFeb 16, 2023Break; Break
IT WAS REPORTED THAT ALL PIECES WERE BROKEN DURING STERILIZATION. TWO FB ARTICULATION SURFACES WERE BROKEN IN HALF. ONE ARTICULATION SURFACE BROKE OFF AND A PIECE IS STUCK IN THE SHIM WHICH IS ALSO BEING SENT BACK. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16389364 ↗MalfunctionJan 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ARTIC SURFACE PIECE WAS DEFECTIVE. ONE HAS MISSING SPRING ON PRONG, OTHER HAS WARPED PRONG WITH DESTROYED SPRING. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16098249 ↗MalfunctionAug 16, 2022Break; Break
IT WAS REPORTED THAT THE SZ 8 FB ARTIC SURFACE BROKE, ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15234018 ↗MalfunctionNov 7, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE INSTRUMENT WAS BROKEN INTO MORE THAN 2 PIECES. THE PIECE IS AVAILABLE FOR RETURN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12759462 ↗MalfunctionOct 15, 2021Break; Break
ATTUNE TRIAL ARTICULATING SURFACE BROKE DURING REDUCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12641021 ↗MalfunctionJan 4, 2021Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT 2 ARTIC SURFACE PIECES THAT ARE CHIPPED, AND HAVE BENT PRONGS. THE DECONTAM DEPARTMENT BROUGHT THIS TO MY ATTENTION. NOBODY WAS INJURED, AND NO SURGICAL CASE WAS DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11109435 ↗MalfunctionJul 10, 2020Break; Crack; Break; Crack
IT WAS REPORTED THAT THE CENTRAL STERILE DEPARTMENT NOTIFIED OF A BROKEN ARTIC SURFACE SIZE 8. THIS WAS STILL ONE PIECE, BUT WAS BROKEN ALMOST HALF WAY THROUGH TRIAL. THIS DID NOT DELAY A CASE. NO ONE WAS INJURED BY ARTIC SURFACE PIECE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10259127 ↗MalfunctionMay 18, 2020Component Missing; Material Twisted/Bent; Component Missing; Material Twisted/Bent
IT WAS REPORTED THAT THE ARTIC SURFACE HAS A BENT PRONGS AND MISSING A SPRING. CENTRAL STERILE HAS REQUESTED A NEW ONE. THIS WAS NOT USED IN A CASE SO DID NOT DELAY SURGERY. NO ONE WAS INJURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10067629 ↗MalfunctionFeb 18, 2020Break; Break
IT WAS REPORTED THAT THE PLASTIC TAB BROKE OFF DURING TRIALING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9722769 ↗MalfunctionJan 8, 2020Break; Break
IT WAS REPORTED THAT THE SPRING AROUND THE COIL BROKE DURING EXTRACTION OF TRIAL ARTICULATE SURFACE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9565559 ↗MalfunctionNov 8, 2019Break; Break
IT WAS REPORTED THAT THE SPRING WAS BROKEN. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9296047 ↗MalfunctionNov 4, 2019Break; Break
IT WAS REPORTED THAT DURING THE TKA PROCEDURE, DOCTOR WAS REMOVING ATTUNE PS FB SHIM, SIZE 8. THE SHIM BROKE IN HALF. BOTH PIECES WERE RETRIEVED FROM THE PATIENT. THE PRODUCT CODE WAS LEGIBLE AND THE PRODUCT WAS DAMAGED TO THE BROKEN SHIM. NOT SURE IF THE LOT NUMBER IS CORRECT. ONLY NUMBERS ON TRIAL SHIM. NO ADDITIONAL INFORMATION AVAILABLE. PLEASE SEND REPLACEMENT SHIM TO WNC TEAM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9274772 ↗MalfunctionMar 21, 2019Break; Break
BROKEN INSTRUMENTS DURING AN UNSPECIFIED SURGERY. NO DELAY IN SURGERY. SURGERY COMPLETED SUCCESSFULLY. NO FRAGMENTS GENERATED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8439392 ↗MalfunctionJun 1, 2018Naturally Worn; Naturally Worn
INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7560183 ↗MalfunctionMay 31, 2018Break; Break
IT WAS REPORTED THAT SIZE 8 FB ARTIC SURF WAS FOUND TO HAVE A CHIP MISSING FROM THE FRONT OF IT DURING THE DECONTAMINATION PROCESS. NO PATIENT WAS INVOLVED IN THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7557600 ↗MalfunctionFeb 26, 2018Break; Break
DER STATED THAT THE ATTUNE SIZE 8 FB ARTICULATING SURFACE TRAY BROKE INTO TWO SEPARATE PIECES WHILE THE DOCTOR WAS REMOVING IT AFTER TRIALING. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7297306 ↗MalfunctionJan 31, 2018Break; Break
IT WAS REPORTED THAT SIZE 8 SPRING BROKEN ON ARTICULATING SURFACE AND SIZE 7 NUB BROKE OFF NEAR SPRING ARTICULATING SURFACE. NO SURGICAL DELAY. NO PIECES OF BROKEN INSTRUMENTATION LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7230486 ↗MalfunctionDec 20, 2017Break; Break
IT WAS REPORTED THAT SPRING BROKE OFF OF TRIAL ARTICULATION SURFACE UPON REMOVAL. NO SURGICAL DELAY. NO PIECES OF BROKEN INSTRUMENTATION LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7135021 ↗MalfunctionNov 17, 2017Break; Break
IT WAS REPORTED THAT THE TRIAL HAS BROKEN INTO THREE PIECES.
Patient problems: No Information
MAUDE report 7041116 ↗MalfunctionNov 13, 2017Break; Break
IT WAS REPORTED THAT THE TIBIAL TRIAL WAS BROKEN WHEN TRIALING. THE RING WAS BUSTED ON BOTTOM SIDE OF ARTICULATING SURFACE.
Patient problems: No Information
MAUDE report 7026343 ↗MalfunctionOct 19, 2017Break; Break
DER STATES THAT THE ATTUNE CONV FB PS TB TRL SZ8 WAS IN SPD, WITH THE BROKEN PIECE INCLUDED, AFTER BEING REMOVED FROM THE WASH.
Patient problems: No Information
MAUDE report 6960915 ↗
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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 · 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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