ATTUNE 2545-00-976Recalls & reported problems
Depuy (Ireland) · ATTUNE CONV FB PS ARTICULATION SURFACE SIZE 6 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE knee implant trial insert is used to try different sizes and fit during knee replacement surgery. Most of the 37 reports describe the plastic trial part breaking, cracking, chipping, or snapping during surgery, sometimes into two pieces that the surgeon had to remove; a few also mention a small wire spring missing from the instrument. There are no deaths and no injuries. One recall from June 2015 concerned that spring, which could come loose and enter the surgical site; it was terminated.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295135531), received between Jul 12, 2017 and May 8, 2026 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Break” (32 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, 2015Terminated
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
- Break32
- Component Missing2
- Crack2
- Illegible Information2
- Material Deformation2
- Bent1
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient17
- No Clinical Signs, Symptoms or Conditions14
- No Information4
- Insufficient Information1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Break
IT WAS REPORTED THAT THE ATTUNE KNEE ARTICULATING SURFACE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125684 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE POLYETHYLENE TRIAL SNAPPED IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052793 ↗MalfunctionJul 7, 2025Break; Break
IT WAS REPORTED THAT UPON REMOVING THE SIZE 6 FB INSERT TRIAL, THE SURGEON NOTICED THAT THE INSERT CRACKED INTO 2 PIECES. SURGEON REMOVED ALL PARTS FROM THE KNEE. ADDED NO TIME TO THE PROCEDURE AND NO HARM TO THE PATIENT. ALL PIECES WERE REMOVED AND CONFIRMED BROKEN PART WAS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412457 ↗MalfunctionDec 26, 2024Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TRIAL WAS BROKEN WHILE BEING REMOVED.
Patient problems: Insufficient Information
MAUDE report 21019660 ↗MalfunctionFeb 18, 2024Break; Crack; Break; Crack
IT WAS REPORTED THAT THE TRIALS IS CHIPPED/DAMAGED. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728546 ↗MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT SPRING OF THE INSTRUMENT IS MISSING FROM THE ARTICULATION SURFACE TRIAL. 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, IP-01939388 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 18493859 ↗MalfunctionNov 17, 2023Break; Break
IT WAS REPORTED THAT FB PS TIBIAL INSERT TRIAL SNAPPED UPON 2 FEMUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18158662 ↗MalfunctionOct 24, 2023Break; Break
IT WAS REPORTED THAT THE ATTUNE ARTICULATING SURFACE TRIAL BROKE IN TWO PIECES UPON IMPACTION DURING SURGERY. THERE WAS NO DELAY TO SURGERY CAUSED BY THIS, AND NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17996266 ↗MalfunctionMar 21, 2023Break; Break
IT WAS REPORTED THAT ARTICULATE SURFACE CRACKED INTO TWO PIECES WHILE TRIALING. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16581924 ↗MalfunctionMar 8, 2023Break; Break
IT WAS REPORTED THAT A TIBIAL IMPACTOR WAS CRACKED DURING THE IMPACTION OF THE IMPLANTS. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16504106 ↗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 16389384 ↗MalfunctionJan 20, 2023Break; Break
IT WAS REPORTED THAT THE TIBIAL TRAY TRIAL WAS BROKEN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16218082 ↗MalfunctionOct 24, 2022Break; Break
IT WAS REPORTED THAT THE PEG ON BOTTOM OF INSERT BROKE OFF DURING SURGERY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15659719 ↗MalfunctionOct 7, 2022Break; Break
IT WAS REPORTED THAT THE PS FB SIZE 6 TRIAL INSERT BROKE DURING TRIALLING. ALL PIECES REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15561690 ↗MalfunctionFeb 21, 2022Break; Break
SPRING BROKE OFF OF TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13572383 ↗MalfunctionNov 9, 2020Break; Break
ADDITIONAL INFORMATION RECEIVED STATED THAT THE WHOLE TRIAL BROKE IN TWO PIECES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10810415 ↗MalfunctionSep 22, 2020Use of Device Problem; Component Missing; Material Deformation; Material Twisted/Bent; Use of Device Problem; Component Missing; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT THE CENTRAL STERILE DEPARTMENT HAS INDICATED THEY HAVE SEVERAL BROKEN DEPUY ITEMS. A SPACER BLOCK THAT ON THE EXTENSION END HAS ONE BENT/BROKEN PRONG, MISSING A SPRING, WHILE THE OTHER SIDE HAS A WARPED SPRING. A 3 FB ARTIC SURF THAT IS MISSING A SPRING ON THE PRONG, AND HAS A WARPED PRONG ON OPPOSITE SIDE. A SIZE 6 FB ARTIC SURF WITH A BENT PRONG, AND MISSING SPRING. A 8 ARTIC SURFACE THAT IS MISSING A SPRING. NONE OF THESE ITEMS CAUSED A DELAY IN ANY SURGERY. NOBODY WAS INJURED BY THESE MISSING PIECES, OR BROKEN PIECES.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10569803 ↗MalfunctionApr 15, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR SIZES CAN¿T BE READ ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9964460 ↗MalfunctionApr 15, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN OR SIZES CAN¿T BE READ ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9964457 ↗MalfunctionMar 23, 2020Break; Break
IT WAS REPORTED THAT THE TRIAL WAS BROKEN WHEN TRYING TO REMOVE FROM KNEE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9868230 ↗MalfunctionDec 27, 2019Break; Break
IT WAS REPORTED THAT THE PIECE OF PLASTIC BROKE OFF THE PEG THAT HOLDS THE SPRING IN PLACE. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9525864 ↗MalfunctionDec 26, 2019Break; Break
ATTUNE PS ARTICULATION SURFACE SZ6 CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9520742 ↗MalfunctionOct 11, 2019Break; Break
IT WAS REPORTED THAT WHEN REMOVING THE SIZE 6 ATTUNE FB PS TRIAL, THE POSTERIOR CORNER BROKE OFF INTO 2 PIECES. ALL PIECES WERE RETRIEVED. 1 MINUTE SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 9180899 ↗MalfunctionSep 30, 2019Break; Break
ATTUNE INSERT TRIALS SPRINGS ARE BROKEN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9135444 ↗MalfunctionMay 23, 2019Break; Break
I WAS REPORTED THAT THE NIPPLE OF THE POLY CONNECTION BROKE OFF. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637908 ↗
Other TEMPLATE devices
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- 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
- 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 16, 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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