ATTUNE 2544-01-011Recalls & reported problems
Depuy (Ireland) · ATTUNE ALIGNMENT HANDLE · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune alignment handle is used during knee replacement surgery. Its 150 reports mostly describe parts that break or wear down, such as red tabs and prongs, and handles that do not stay securely on trays. The reports include no deaths and no injuries. No recalls name this device.
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
- 153
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10603295130260), received between Oct 25, 2017 and Sep 25, 2026 — classified as 153 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (82 reports).
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
Most reported problems
Device problems
- Device-Device Incompatibility82
- Break40
- Material Deformation20
- Naturally Worn7
- Material Twisted/Bent5
- Crack4
- Incorrect Measurement3
- Unintended Movement3
Patient problems
- No Clinical Signs, Symptoms or Conditions110
- Insufficient Information27
- No Consequences Or Impact To Patient15
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Break
It was reported that black alignment handle for tibial base plate trial broke. The red actuator piece was recovered but inadvertently was thrown in the trash.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898820 ↗MalfunctionSep 21, 2026Break
It was reported that the tibia Handle was broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841491 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740495 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455555 ↗MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452655 ↗MalfunctionJun 25, 2026Break
IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT NOTIFIED OF A BROKEN FEMORAL IMPACTOR AS WELL AS A BROKEN TIBIAL ALIGNMENT HANDLE. ALIGNMENT HANDLE RED TAB WAS BROKEN OFF AND THROWN AWAY. THE FEMORAL IMPACTOR WAS THROWN AWAY DUE TO HEAVY SCARRING AND NO LONGER FELT IT WAS ABLE TO KEEP STERILE. NOTHING FURTHER TO REPORT. THE EVENT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25619796 ↗MalfunctionMay 18, 2026Material Deformation
IT WAS REPORTED DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE BLACK TIBIA HANDLE PRONGS BENT UPON REMOVAL OF THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209805 ↗MalfunctionMar 5, 2026Break
IT WAS REPORTED THAT THERE WAS THE PLASTIC LOOSENING FROM THE TIBIAL HANDLE IN THE HOLE INTENDED FOR THE ALIGNMENT ROD. THE EVENT WAS IDENTIFIED POST-OPERATIVELY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24521770 ↗MalfunctionMar 3, 2026Break
IT WAS REPORTED THAT RED TAB ON THE BLACK ALIGNMENT HANDLE BUSTED. A SMALL PIECE ON ONE OF THE LOCKING TABS FOR THE SHIM BROKE OFF AND CAN NO LONGER BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494765 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451439 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451438 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451435 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451434 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451433 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451432 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451431 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451430 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451429 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451428 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451359 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451358 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451355 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451354 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451353 ↗MalfunctionFeb 26, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE TRAY HANDLES WOULDN'T SECURELY STAY ON TRAY TRIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24451352 ↗
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
- 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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