ATTUNE 2544-01-003Recalls & reported problems
Depuy (Ireland) · ATTUNE TIBIAL IMPACTOR FIXED BEARING · Class 1
All models of ATTUNE (1475)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy ATTUNE tibial impactor is a surgical tool used to tap in knee implants during surgery. The 1,501 reports most often describe the instrument breaking or cracking, and some describe worn or scratched parts. The reports list no deaths and 4 injuries. One closed recall names this device, which started in November 2014, over impactors that broke into small pieces that could be left 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
- 1,498
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,498 adverse event reports that list this exact device (DI 10603295130192), received between Jun 26, 2017 and Sep 30, 2026 — classified as 4 injuries, 1,494 malfunctions.
The most frequently reported specific device problem is “Break” (1,383 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
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Z-0903-2015 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break1,383
- Crack154
- Naturally Worn22
- No Apparent Adverse Event12
- Scratched Material11
- Adverse Event Without Identified Device or Use Problem8
- Contamination /Decontamination Problem6
- Material Deformation6
Patient problems
- No Clinical Signs, Symptoms or Conditions820
- No Consequences Or Impact To Patient495
- Insufficient Information95
- No Information84
- No Code Available19
- Not Applicable11
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 1,498 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
It was reported that the Attune Modular Fixed Bearing Impactor was broken into two pieces when being used to implant tibial prosthesis. It was reported that no fragments went into the patient. There was no patient or user harm. There was no significant delay.Attune Fixed Bearing Tibial Impactor - Modular: Joint Reconstruction.Side Affected: Left Side.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945169 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934787 ↗MalfunctionSep 24, 2026Break; Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884942 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846413 ↗MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776076 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721009 ↗MalfunctionSep 9, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698459 ↗MalfunctionAug 17, 2026Break; Crack
It was observed by Central Supply that the Attune FB Tibial impactor was cracked. Was there any reported patient or user harm? No.Was there a significant delay? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280802 ↗MalfunctionAug 14, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261278 ↗MalfunctionAug 13, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233798 ↗MalfunctionJul 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060504 ↗MalfunctionJul 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25838119 ↗MalfunctionJul 1, 2026Break
IT WAS REPORTED THAT THE REPORTED DEVICE WAS BROKEN WHILE IMPACTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680605 ↗MalfunctionJun 24, 2026Break
IT WAS REPORTED THAT ITEM WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606694 ↗MalfunctionJun 10, 2026Break
IT WAS REPORTED THAT DURING IMPLANTATION THE IMPACTOR SPLIT IN HALF. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25455758 ↗MalfunctionJun 5, 2026Break; Crack
IT WAS REPORTED THAT WHILE SEATING THE CEMENTLESS TIBIA TRAY, THE FB TIBIA IMPACTOR CRACKED AND BROKE INTO 2 PIECES. THE TIBIA WAS FULLY SEATED THEREFORE THERE WAS NO SURGICAL DELAY. THE 2 BROKEN PIECES WERE RETRIEVED AND WOULD BE RETURNED. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25413597 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT DURING A KNEE SURGERY, THE IMPACTOR DEVICE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375897 ↗MalfunctionMay 20, 2026Break
IT WAS REPORTED THAT FB TIBIAL IMPACTOR BROKE DURING IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230296 ↗MalfunctionMay 14, 2026Break
IT WAS REPORTED THAT AFTER THE PROCEDURE, IT WAS OBSERVED THAT THE IMPACTOR WAS BROKEN. IT WAS FURTHER REPORTED THAT THE PART DID NOT BREAK IN HALF, A PIECE WAS BROKEN OFF THE IMPACTOR. THE DEVICE WAS NOT USED DURING THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176721 ↗MalfunctionMay 11, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPENED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25137716 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT AFTER A SURGICAL PROCEDURE IT WAS OBSERVED THAT THE FB TIBIAL IMPACTOR WAS BROKEN. NO IMPACT TO PATIENT OP DATE [REDACTED]. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096373 ↗MalfunctionMay 6, 2026Crack
IT WAS REPORTED THAT IMPACTOR CRACKED WHILE IMPLANTING TIBIAL COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096165 ↗MalfunctionMay 6, 2026Break
IT WAS REPORTED THAT THE IMPACTOR BROKE INTO TWO PIECES WHILE IMPLANTING THE TIBIAL COMPONENT. ALL PIECES RETRIEVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25093110 ↗MalfunctionMay 1, 2026Crack
IT WAS REPORTED THAT ITEM CRACKED DURING THE CASE; ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY IN THE SURGICAL TIME, NOR WAS THE PATIENT AFFECTED IN ANY WAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058645 ↗MalfunctionMay 1, 2026Break
IT WAS REPORTED THAT FB IMPACTOR BROKE WHILE IMPACTING TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25055644 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 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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