ATTUNE 2545-00-566Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM CRUCIATE RETAINING SIZE 6 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DePuy ATTUNE rotating-platform knee implant, used during knee replacement surgery. Most of the 58 reports describe parts breaking or coming apart during surgery — cracked liners, springs or small wire coils detaching, and pieces breaking off — sometimes leaving loose fragments in the patient. There are no deaths and no injuries. One recall, started in June 2015 and since closed, involved the trial instruments' small wire spring coil breaking free and potentially entering 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
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295133063), received between Oct 5, 2017 and Sep 11, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Break” (42 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-2141-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break42
- Detachment of Device or Device Component13
- Crack4
- Device-Device Incompatibility3
- Entrapment of Device3
- Material Deformation3
- Adverse Event Without Identified Device or Use Problem2
- Component Missing2
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Consequences Or Impact To Patient15
- No Code Available3
- No Information3
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Break
It was reported that during a surgical procedure, the femoral impactor and CR trail liner broke during use.Was there any reported patient or user harm? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732795 ↗MalfunctionAug 18, 2026Break; Illegible Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299010 ↗MalfunctionMay 27, 2026Break
IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIAL DEVICE HAD A BROKEN LINER. IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN INTO TWO OR MORE PIECES. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300279 ↗MalfunctionDec 12, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT SIZE 6 RP TRIAL CRACKED INTO TWO & SO DID THE 6MM SHIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23794356 ↗MalfunctionNov 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRINGS SPANNED OFF IN COUPLE OF PROCEDURES BUT BECAUSE THEY HAVE TWO IN EACH TRAY THE HOSPITAL WAITED TILL THEY RAN OUT OF THEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23497540 ↗MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SPRINGS SPANNED OFF THE ATTUNE ARTICULATION SURFACE ROTATING PLATE CRUCIATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23479215 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE ARTIC SURF BROKE DURING THE SURGERY WHEN TAKING OUT THE POLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795377 ↗MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A SPRING HAS BEEN LOST FROM THE ARTICULATING SURFACE DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22629368 ↗MalfunctionJun 18, 2025Break; Break
IT WAS REPORTED THAT ATTUNE INSTRUMENTS ARE BROKEN AND WORN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288313 ↗MalfunctionMay 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT SPRINGS ON PARTICULAR SURFACE TRIALS WERE MISSING AFTER INSTRUMENTS WERE CLEANED. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22026422 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. THE ATTUNE ARTICULAR SURFACE TRIAL HAD A BROKEN TAB. ALL PIECES ACCOUNTED FOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881435 ↗MalfunctionDec 9, 2024Break; Break
IT WAS REPORTED THAT THE A SMALL PLASTIC POST OF THE INSTRUMENT HAS BROKEN OFF FROM THE MAIN PLASTIC COMPONENT OF THIS INSTRUMENT WHICH RENDERS THIS INSTRUMENT UN-USABLE IN THEATRE. ALL PIECES WERE RETRIEVED. THIS DID NOT BREAK IN THEATRE OR IN USE IN A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20883473 ↗MalfunctionNov 15, 2024Break; Break
IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN, IT WAS IDENTIFIED THAT THE FOOT AND SPRING SNAPPED OFF. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20699011 ↗MalfunctionOct 31, 2024Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2024, THE SPRING THAT GOES UNDERNEATH THE TRIAL AND SECURES IT TO THE SHIMS HAS BROKEN. THIS WAS NOTICED DURING CLEANING. THERE WAS NO IMPACT TO SURGERY OR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579539 ↗MalfunctionOct 21, 2024Break; Break
IT WAS REPORTED THAT UPON TRIALING THE INSERT, THE SHIM AND TRIALING SURFACE BROKE AT THE INTERFACE. ALL PARTS WERE REMOVED FROM SURGERY THERE WAS NO HARM TO THE PATIENT OR DELAY TO THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493296 ↗MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING RING WAS MISSING. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091574 ↗MalfunctionAug 12, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THERE WAS A BROKEN ATTUNE ARTICULATING SURFACE. IT BROKE DURING CASE WHEN SURGEON WAS REMOVING ITEM FROM PATIENT DURING TRIALING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19960941 ↗MalfunctionJul 23, 2024Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE INSERT WAS MISSING PIECE FROM WEAR.
Patient problems: Insufficient Information
MAUDE report 19804333 ↗MalfunctionMar 27, 2024Break; Entrapment of Device; Break; Entrapment of Device
ADDITIONAL INFORMATION WAS RECEIVED: 1. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO 3. CAN YOU PLEASE PROVIDE THE DATE OF EVENT? 6TH MARCH 4. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY THE ALLEGED DEFICIENCY OF THE INSTRUMENTS. WERE THEY BENT, STRIPPED, CROSS THREADED, ETC.? NO WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? NO.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 18986815 ↗MalfunctionJan 11, 2024Break; Break
THE RP CR ARTICULATION SURFACE HAVE DAMAGED SPRINGS. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18496524 ↗MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING IS MISSING FROM THE ARTICULATION SURFACE SZ 6. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18494336 ↗MalfunctionOct 4, 2023Break; Crack; Material Deformation; Break; Crack; Material Deformation
IT WAS REPORTED THAT ONE OF THE STEMS ON THE BACK OF THE ITEM IS CRACKED AND CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17867932 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT HAD BEEN CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17598427 ↗MalfunctionJun 20, 2023Break; Break
IT WAS REPORTED THAT THE SHIM WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162569 ↗MalfunctionMay 18, 2023Break; Break
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16952972 ↗
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
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- 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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