ATTUNE 2545-00-545Recalls & reported problems
Depuy (Ireland) · ATTUNE ARTICULATION SURFACE ROTATING PLATFORM POSTERIOR STABLIZED SIZE 5 · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE knee articulation surface is a trial component used during knee replacement surgery. Its 219 reports mostly describe parts breaking, cracking or coming loose, and many note no harm to the patient. The reports include 1 injury and no deaths. There is 1 closed recall, from June 2015, over a small spring coil on the instruments that could come off and enter the surgical site. Reports fell from 21 in the prior 12 months to 9 in the latest 12 months.
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
- 221
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 10603295132851), received between Jun 28, 2017 and Sep 29, 2026 — classified as 1 injury, 220 malfunctions.
The most frequently reported specific device problem is “Break” (168 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-2139-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break168
- Detachment of Device or Device Component29
- Crack9
- Component Missing8
- Material Deformation8
- Device-Device Incompatibility4
- Entrapment of Device4
- Use of Device Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions123
- No Consequences Or Impact To Patient73
- No Information14
- Insufficient Information8
- No Code Available5
- Device Embedded In Tissue or Plaque1
- Discomfort1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 221 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
It was observed by Central Supply that the Attune Artic Surf was missing a spring. It was reported that there was no significant delay. There was no patient or user injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930497 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930441 ↗MalfunctionJun 11, 2026Break
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THERE WERE BROKEN CONSIGNMENTS SIZE 7 PS RP ARTICULATING SURFACE TRIAL, SIZE 5 PS RP ARTICULATING SURFACE TRIAL, AND RIGHT FEMORAL TRIAL PS SIZE 8 FROM PS NOTCH SIZE 3-5 TRAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477886 ↗MalfunctionMay 12, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT TKA FOR KNEE OA ON THE RIGHT SIDE. AT WOUND CLOSURE, WHEN A NURSE REMOVED THE SHIM ASSEMBLED TO THE DEVICE, THE METAL SPRING RING USED TO SECURE THE SHIM BECAME DISLODGED (SIZE #4 PSRP). THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. LOOSENING OF THE SAME SPRING RING WAS CONFIRMED IN THE SIZE #3 PSFB AND SIZE #5 PERP INSERT TRIALS. THE SURGEON CONFIRMED BY X-RAY THAT NO BROKEN FRAGMENTS OR COMPONENTS REMAINED IN THE PATIENT¿S BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25152326 ↗MalfunctionApr 8, 2026Crack
IT WAS REPORTED THAT THE DURING INSPECTION IN SPD IT WAS NOTICED THAT INSTRUMENTS WERE CRACKED. THEY DID NOT BREAK IN ANY PIECES JUST CRACKED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821949 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT THERE IS HOLE IN POLY TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457220 ↗MalfunctionFeb 26, 2026Break
IT WAS REPORTED THAT THERE IS HOLE IN POLY TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457214 ↗MalfunctionFeb 24, 2026Break
IT WAS REPORTED THAT THE KNOB ON THE ARTICULATION SURFACE WAS BROKEN. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24429796 ↗MalfunctionNov 24, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TRIAL DEVICE BROKE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23632923 ↗MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING "SSD", IT WAS OBSERVED THAT THE SPRING BECAME LOOSE AND WAS DEEMED UNUSABLE. THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542390 ↗MalfunctionNov 6, 2025Break; Break
IT WAS REPORTED THAT THE ATTACHMENT PEG ON UNDERSIDE OF TRIAL SHIM SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487103 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE TIBIAL TRIALS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438738 ↗MalfunctionOct 31, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435899 ↗MalfunctionSep 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIECE OF PLASTIC WAS MISSING WHERE LOT NUMBER WAS SUPPOSED TO BE. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976589 ↗MalfunctionSep 4, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ARTICULATING PEG HAS SHEARED OFF THE UNDERSIDE OF THE ART SURFACE TRIAL. IT IS EVIDENT IN THE PICTURE SUPPLIED, LEFT HAND SIDE OF PICTURE BETWEEN THE WORDS ATTUNE AND DEPUY. SINGLE PIECE BROKEN OFF AND DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22964813 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE SHIM TRIAL WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22797951 ↗MalfunctionJul 24, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND WITHIN A BROKEN INSTRUMENTS TUB AT HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22588430 ↗MalfunctionJun 30, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN POLY TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357280 ↗MalfunctionJun 10, 2025Crack; Crack
IT WAS REPORTED THE INSTRUMENTS WERE CRACKED. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22177947 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THE PEG ON THE BOTTOM OF THE SIZE 5 RP TRIAL BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140335 ↗MalfunctionJun 4, 2025Break; Break
IT WAS REPORTED THAT THE PEG ON THE BOTTOM OF THE SIZE 5 RP TRIAL BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140333 ↗MalfunctionMay 15, 2025Break; Break
IT WAS REPORTED THE ITEMS WERE CHIPPING.
Patient problems: Insufficient Information
MAUDE report 22031142 ↗MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED THAT WHILE TRIALING THE POSTED AND SPRING IN THE BOTTOM OF THE PS SURFACE BROKE OFF. IT WAS RETRIEVED AND NO HARM TO THE PATIENT. THERE WAS NO ADVERSE EFFECTS AND NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22005420 ↗MalfunctionApr 30, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT SPD STATED THAT THE ITEM WAS BROKEN AND CRACKED/DAMAGED ON THE POSTERIOR UNDER SURFACE AND CANNOT BE RE-PROCESSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936037 ↗MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT SZ 5 ATTUNE RP INSERT HAS A DAMAGED POST AND A BROKEN SPRING. THERE WAS NO SURGICAL DELAY. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21654361 ↗
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
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
- ATTUNE 2545-00-526Depuy (Ireland) · TEMPLATE1 recall218 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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