ATTUNE 2544-01-017Recalls & reported problems
Depuy (Ireland) · ATTUNE IMPACTION HANDLE · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE impaction handle is a surgical tool used to seat knee implants. The 1,466 reports most often describe the instrument breaking, with some describing cracks and parts coming loose. The reports list no deaths and 3 injuries. One closed recall names this device, which started in November 2014, over a lever that could fracture during impaction and leave fractured pieces in a patient if not seen during surgery.
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
- 1,456
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,456 adverse event reports that list this exact device (DI 10603295423324), received between Jun 22, 2017 and Sep 29, 2026 — classified as 3 injuries, 1,453 malfunctions.
The most frequently reported specific device problem is “Break” (1,335 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
- Nov 10, 2014Terminated
Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
Z-0953-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1,335
- Device-Device Incompatibility47
- Crack21
- Detachment of Device or Device Component16
- Naturally Worn13
- Adverse Event Without Identified Device or Use Problem11
- Contamination /Decontamination Problem11
- No Apparent Adverse Event11
Patient problems
- No Clinical Signs, Symptoms or Conditions660
- No Consequences Or Impact To Patient630
- No Information89
- Insufficient Information66
- No Code Available27
- Not Applicable15
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 1,456 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Unintended Movement
It was reported that during impaction of the tibial implant, the impaction handle spring broke loose. All pieces were retrieved and this did not delay the surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928850 ↗MalfunctionSep 22, 2026Break
It was reported that during an unspecified surgical procedure it was observed that the spring/trigger of the impaction handle mechanism sheared off as it was being used to impact the femur during cementing. It was reported that there was no delay in the procedure due to the event. It was reported that there was no injury to the patient. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852441 ↗MalfunctionAug 14, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261475 ↗MalfunctionAug 5, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147687 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50045925 ↗MalfunctionJul 6, 2026Break
IT WAS REPORTED THAT THE RED LATCH ON THE ATTUNE IMPACTION HANDLE BROKE DURING IMPACTION. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25724237 ↗MalfunctionJul 6, 2026Break
IT WAS REPORTED THAT ATTUNE IMPACTION HANDLE BROKE AS SURGEON WAS IMPACTING THE FEMORAL COMPONENT. IT DID NOT CAUSE ANY ISSUE WITH THE CASE AND NO FURTHER COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25718784 ↗MalfunctionJul 2, 2026Break
IT WAS REPORTED THAT ATTUNE IMPACTOR HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25689411 ↗MalfunctionJun 24, 2026Break
DURING IMPLANTATION OF A CEMENTLESS FEMORAL COMPONENT, THE RETAINING CLIP MECHANISM ON THE IMPACTION HANDLE FRACTURED AND BECAME DETACHED FROM THE INSTRUMENT. INSPECTION OF THE INSTRUMENT IMMEDIATELY FOLLOWING THE EVENT IDENTIFIED THAT THE SPRING LOADED RETAINING CLIP HAD BROKEN. THE DETACHED COMPONENTS CONSISTED OF THE RETAINING CLIP AND SPRING MECHANISM. NO INJURY OCCURRED TO THE PATIENT, NO COMPROMISE TO THE IMPLANT POSITIONING OR FIXATION, NO FRAGMENTS REMAINED WITHIN THE SURGICAL SITE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND UNEVENTFULLY WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610466 ↗MalfunctionJun 19, 2026Break
IT WAS REPORTED THAT THE RED CLIP OF THE IMPACTION HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25560612 ↗MalfunctionJun 19, 2026Break
IT WAS REPORTED THAT THE RED CLIP OF THE IMPACTION HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25560544 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT DURING IMPACTION OF THE IMPLANT THE IMPACTION HANDLE BROKE. IT DID NOT IMPACT THE LENGTH OF THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25549703 ↗MalfunctionMay 26, 2026No Apparent Adverse Event
ITEM WAS REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276855 ↗MalfunctionMay 12, 2026Break
IT WAS REPORTED THAT THE LOCKING BUTTON IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25149764 ↗MalfunctionMay 8, 2026Break
IT WAS REPORTED THAT THE LEVER ON HANDLE WAS BROKEN OFF. THE EVENT DID NOT HAPPEN IN SURGERY. NO ISSUES TO PATIENT. NO ISSUES TO SURGEON. NO DELAY. ALL BROKEN PIECES RETRIEVED. NO FURTHER PROBLEMS TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124901 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT DURING IMPACTION THE HANDLE BROKE. ALL PIECES WERE RETRIEVED. NO HARM TO PATIENT. NO DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096779 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT THE ATTUNE HANDLE BROKE APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059985 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT THE BUTTON ON THE ATTUNE IMPACTION HANDLE WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25020349 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT THE BUTTON ON THE ATTUNE IMPACTION HANDLE WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24983056 ↗MalfunctionApr 24, 2026Break
IT WAS REPORTED THAT WHILE USING THE IMPACTOR THE LOCKING LEVER BROKE OFF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24982879 ↗MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT HANDLE BROKE DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942630 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT THE IMPACTION HANDLE BROKE DURING IMPLANTATION. NO TIME WAS ADDED TO THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24930469 ↗MalfunctionApr 16, 2026Break
IT WAS REPORTED THAT IMPACTOR HANDLE LOCKING MECHANISM BROKE DURING TIBIAL IMPACTOR. IMPACTOR FEMORAL LOCKED DURING FEMORAL IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896000 ↗MalfunctionApr 11, 2026Break
IT WAS REPORTED THAT AN ATTUNE IMPACTION HANDLE WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851988 ↗MalfunctionApr 7, 2026Material Deformation
IT WAS REPORTED THAT THERE WAS A BURR ON IMPACTOR HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809301 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
- SELF CENTERING 2055-13-000Depuy (Ireland) · IMPACTOR324 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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