ATTUNE 2545-00-506Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE FIXED BEARING POSTERIOR STABILIZED SIZE 6 · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune articulation surface is a sizing template used during knee replacement surgery. Its 147 reports describe the component breaking, parts detaching, and broken springs, and many report no effect on patients. The reports include no injuries and no deaths. One recall names this device and is closed, started in June 2015, over springs that can come off into 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
- 147
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 10603295132462), received between Jun 29, 2017 and Apr 6, 2026 — classified as 147 malfunctions.
The most frequently reported specific device problem is “Break” (111 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-2137-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break111
- Detachment of Device or Device Component28
- Material Deformation14
- Appropriate Device Problem Term/Code Not Available8
- Component Missing8
- Crack5
- Material Twisted/Bent4
- Device-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- No Consequences Or Impact To Patient59
- No Information5
- Insufficient Information4
- No Code Available2
Recent adverse event reports
The 25 most recent of 147 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ARTICULATION SURFACE FB SZ 6 WAS BROKEN. A PIECE OF THE MATERIAL HAS BROKEN OFF. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, NOR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ATTUNE FB PS ARTIC SURF SZ6: RIGHT SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788628 ↗MalfunctionJan 16, 2026Break
IT WAS REPORTED THAT SPRINGS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096498 ↗MalfunctionDec 22, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE POST ON THE UNDERSIDE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862559 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE PS SIZE 6 ARTICULATING SURFACE BROKE WHILE TAKING IT OUT OF THE ONE. ALL PIECES WERE ACCOUNTED FOR WITHOUT ANY ISSUE. THE 2ND ONE WAS DAMAGED BY REMOVING IT AS WELL BUT NO PIECES BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23572590 ↗MalfunctionNov 17, 2025Break; Break
IT WAS REPORTED THAT THE ATTUNE PS SIZE 6 ARTICULATING SURFACE BROKE WHILE TAKING IT OUT OF THE ONE. ALL PIECES WERE ACCOUNTED FOR WITHOUT ANY ISSUE. THE 2ND ONE WAS DAMAGED BY REMOVING IT AS WELL BUT NO PIECES BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23570831 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT THE SPRING IS BROKEN ON INSERT TRIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965140 ↗MalfunctionSep 4, 2025Break; Break
IT WAS REPORTED THAT WHILE TRIALING, THE PEGS ON THE BACK OF THE FB PS TRIAL PLATE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965087 ↗MalfunctionJul 22, 2025Break; Break
IT WAS REPORTED THAT THE STAR DRIVER TIP IS STRIPPED. THE RELCAIM PIECE'S NUT IS STUCK AND WON'T RELEASE. THE ARTICULATING SURFACE HAS A BROKEN SPRING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22566351 ↗MalfunctionJun 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING LOST OR BROKE ON ATTIC SURF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157705 ↗MalfunctionJan 28, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENT TRIAL IS BROKEN. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21256531 ↗MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE PROCEDURE, WHEN DOING THE FEMUR FIXATION, ONE OF THE FIXING PINS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832529 ↗MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED THAT ONE OF THE STUDS ON THE ARTICULAR SURFACE OF A TRIAL INSERT BROKE AT ITS BASE. THE FRAGMENTS WERE REMOVED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20821136 ↗MalfunctionNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THAT THE TIBIA INSERT FB SIZE 6 DROPPED A SPRING, DURING THE PROCEDURE. BUT, THE USER NOTICED, THE ISSUE IN THE WASH.
Patient problems: Insufficient Information
MAUDE report 20785920 ↗MalfunctionNov 22, 2024Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE BEARING SURFACE BROKE ON THE ITEM. THE SURGERY WAS NOT DELAYED, AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756505 ↗MalfunctionNov 15, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THE INSTRUMENT BROKE DURING KNEE SURGERY. ONE OF THE SPRINGS HAS COME OFF. IT WAS CHECKED PRIOR TO SURGERY. IT DIDN¿T DELAY SURGERY; NOTHING WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696152 ↗MalfunctionOct 30, 2024Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE SPRING ON THE PS ARTICULATING SURFACES BROKE. THE BROKEN SPRING WAS RETRIEVED IN ONE PIECE. THE OTHER ARTICULATING SURFACE ON THE SET WAS USED. THERE WAS NO PATIENT CONSEQUENCE AND THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570075 ↗MalfunctionJul 8, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THAT SPRING ON ARTICULATING SURFACES BECAME STRETCHED AND FELL OFF THE PEG WHILE SWITCHING SHIMS. THERE WAS NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED AND SURGICAL TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688722 ↗MalfunctionMay 9, 2024Break; Break
BEARING SPRING BROKEN OFF OF INSERT TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282183 ↗MalfunctionApr 29, 2024Break; Break
IT WAS REPORTED THAT THE PS SIZE 6 FB INSERT BROKE. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19205849 ↗MalfunctionFeb 18, 2024Break; Crack; Break; Crack
THERE ARE CRACKS AND CHIPS ON THE TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728539 ↗MalfunctionFeb 16, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SPRINGS ARE IRREGULARLY SHAPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18726055 ↗MalfunctionJan 19, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
WITHIN THE PROCEDURE, THE SURGEON REMOVES THE TRIAL INSERT, FB PS TIBIA TRIAL INSERT SIZE 6, FROM THE PATIENT WHO BREAKS A PART OF IT. THE SURGERY WAS UNEVENTFUL, THERE WERE NO INCONVENIENCES OR DELAYS AND THE SURGERY WAS ACCOMPLISHED SUCCESSFULLY AND SMOOTHLY. THE DOCTOR NO LONGER REQUIRED THE TEST. THERE WAS NO IMPACT ON THE PATIENT AND THE BROKEN PART OF THE PIECE REMAINS TOGETHER WITH THE MARKED PIECE INSIDE THE INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18542633 ↗MalfunctionJan 18, 2024Break; Break
IT WAS REPORTED THAT A BEARING BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18540046 ↗MalfunctionJan 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRING WAS MISSING FOR DEVICE. 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 18465177 ↗MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPRINGS ARE MISSING FROM THE ARTICULATION SURFACE TRIALS. 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 18435092 ↗
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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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