ATTUNE 2545-00-999Recalls & reported problems
Depuy (Ireland) · ATTUNE RP PS ARTICULATION SURFACE SIZE 9 · 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 used during knee replacement procedures. The 24 reports mostly describe the insert or its spring breaking, coming loose, or deforming during removal or after use; no deaths or injuries were reported. One closed recall began in June 2015 because a small wire spring on related Attune trial instruments could detach 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 10603295135760), received between Oct 3, 2017 and Aug 26, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Break” (19 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-2143-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break19
- Detachment of Device or Device Component2
- Component Missing1
- Crack1
- Device-Device Incompatibility1
- Material Deformation1
- No Apparent Adverse Event1
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information1
- No Code Available1
- No Information1
- Not Applicable1
Recent adverse event reports
The 24 most recent of 24 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 50453810 ↗MalfunctionJan 14, 2026Break
IT WAS REPORTED THAT THE SPRING IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067320 ↗MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING POPPED OFF OF THE TRIAL. SPRING WAS LOCATED ON THE GROUND IMMEDIATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089663 ↗MalfunctionOct 17, 2024Break; Break
ATTUNE SIZE 9 RP INSERT TIBIAL TRIAL BROKE IN HALF WHILE EXTRACTING IT FOLLOWING TRIAL IMPLANTS. SURGEON USED TIBIAL INSERT EXTRACTOR TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469805 ↗MalfunctionJan 26, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18587709 ↗MalfunctionDec 11, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT DEFORMED LOCKING SPRING ON TRIAL TIBIAL INSERT WAS FOUND DURING POST CASE DECONTAMINATION. THE INSTRUMENT HAS BEEN REMOVED FROM SERVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300539 ↗MalfunctionNov 16, 2022Break; Break
IT WAS REPORTED THAT WHILE EXTRACTING THE TRIAL INSERT, THE ARTICULATING SURFACE BROKE INTO 2 PIECES. NO HARM TO THE PATIENT. ALL PIECES WERE RETRIEVED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15805179 ↗MalfunctionOct 29, 2022No Apparent Adverse Event; No Apparent Adverse Event
THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT: PRODUCT CODE: (B)(4), LOT #: BFA118D. ARRIVED AT CG LABS ON (B)(6) 2022, UNDER TRACKING NUMBER: (B)(4). ISSUE - BROKEN IN TWO PIECES. HOWEVER, IT COULD NOT BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE FROM (B)(4). THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Insufficient Information
MAUDE report 15696827 ↗MalfunctionAug 15, 2022Break; Break
IT WAS REPORTED THAT UPON REMOVAL OF THE SIZE 9 POSTERIOR STABILIZED ROTATING PLATFORM AFTER THE INITIAL COMPONENT TRIALING, THE TRIALING SURFACE WAS CRACKED IN TWO PIECES. ALL PIECES WERE REMOVED FROM SURGERY RIGHT AWAY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15224951 ↗MalfunctionJan 6, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021 DURING SURGERY AN RP PS INSERT TRIAL BROKE DURING TRIAL REMOVAL. BOTH PIECES WERE RETRIEVED. SURGERY CONTINUED AND WAS COMPLETED USING THE 2ND ONE IN THE SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177748 ↗MalfunctionSep 3, 2021Break; Break
IT WAS REPORTED THAT THE SHIM 9-10 6MM BROKE. ALSO TOO THERE IS A FRACTURE IN THE 9-10 MACRO TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12421712 ↗MalfunctionJul 15, 2020Crack; Crack
DURING SURGERY THE SURGEON USED A HAMMER TO PUSH THE TRIAL AND SHIMS INTO PLACE. TWO SHIMS AND ONE TRIAL NOW HAVE CRACKS IN THEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10277726 ↗MalfunctionJun 16, 2020Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN THE 2-PIECE INSERT TRIAL WAS REMOVED FROM THE SURGICAL SITE, THE METAL RING ON THE SHIM DETACHED AND BECAME STUCK ON THE KNOB OF THE ARTICULATION SURFACE, DAMAGING BOTH INSTRUMENTS. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10159234 ↗MalfunctionMar 29, 2019Break; Component Missing; Break; Component Missing
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN MISSING SEAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8465566 ↗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 8196884 ↗MalfunctionAug 24, 2018Break; Break
MAUDE REPORT RECEIVED. DOCTOR WAS PERFORMING A L TKA (TOTAL KNEE ARTHROPLASTY). WHILE REMOVING ARTICULATING SURFACE TRIAL, THE TRIAL, AS WELL AS THE TRIAL EXTRACTOR BROKE. THE TRIAL WAS REMOVED IN ITS ENTIRETY. ALL PIECES OF THE TRIAL EXTRACTOR, HOWEVER, WERE NOT ENCOUNTERED FOR. THE WOUND WAS THOROUGHLY SEARCHED AND IRRIGATED THOROUGHLY, AND NO EVIDENCE OF FOREIGN BDY WAS FOUND. THE TRIAL AND TRIAL EXTRACTOR WERE SEQUESTERED AND SENT TO RISK FOR EVALUATION AND REPORTING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7813502 ↗MalfunctionJul 10, 2018Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN. DIDN'T IMPACT ANY CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7674102 ↗MalfunctionJun 18, 2018Break; Break
DURING A TOTAL KNEE REPLACEMENT A SIZE 9 RP/PS ARTICULAR SURFACE TRIAL AND A 9/10 8MM SHIM WERE BROKEN. ALL PIECES WERE RETRIEVED AND THE CASE WAS NOT DELAYED. PATIENT CONSEQUENCE? NO. ACTION TAKEN FOR PROCEDURE:A NEW SET OF 9/10 INSTRUMENTS AND TRIALS WERE OPENED. 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 7609947 ↗MalfunctionMay 24, 2018Break; Break
IT WAS REPORTED THAT THE TRIAL EXTRACTOR AND ARTICULATING SURFACE BROKE DURING REMOVAL OF TRIALS. ALL PIECES OF THE EXTRACTOR WERE NOT RETRIEVED. THE WOUND WAS SEARCHED THOROUGHLY AND NOTHING WAS FOUND. THE TRIAL AND EXTRACTOR ARE BEING SENT TO RISK MANAGEMENT SO THEY WILL NOT BE RETURNED. SURGICAL DELAY: 5-10 MINS. ALL PIECES OF THE EXTRACTOR WERE NOT RETRIEVED.
Patient problems: No Code Available; Not Applicable
MAUDE report 7540960 ↗MalfunctionApr 20, 2018Break; Break
DURING A TOTAL KNEE THE ARTICULAR WAS TIGHT TO INSERT AND DR. (B)(6) USED A MALLET AND TAPPED THE INSERT AND IT EXPLODED IN HALF. ALL PIECES AND PARTS WERE RECOVERED. 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 7446613 ↗MalfunctionMar 22, 2018Break; Break
DURING A TOTAL KNEE THE ARTICULAR SURFACE WAS TIGHT GOING IN AND THE SURGEON TAPPED IT WITH A MALLET TO FULLY ENGAGE IT IN THE KNEE. THE TABS ON THE ARTICULAR SURFACE BOTH BROKE OFF, BOTH PIECES WERE REMOVED BUT DID NOT MAKE IT WITH THE REST OF THE DIRTY INSTRUMENTS. 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 7363667 ↗MalfunctionMar 21, 2018Break; Break
IT WAS REPORTED THAT THE SIZE 9 RP ARTICULATING SURFACE WAS BROKEN DURING SURGERY. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7357356 ↗MalfunctionFeb 13, 2018Break; Break
IT WAS REPORTED THAT AFTER TRIAL REDUCTION, WHILE TAKING THE SHIM OFF OF THE ARTICULAR SURFACE TRIAL, THE SPRING AND SPRING HOLDER POPPED OFF OF BOTH SIDES. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7267479 ↗MalfunctionOct 3, 2017Break; Break
IT WAS REPORTED THAT THE BALL SEAL WAS BROKEN.
Patient problems: No Information
MAUDE report 6912131 ↗
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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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