INTUITIONRecalls & reported problems across all models
Depuy (Ireland) · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 23 models of INTUITION by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2024 and Sep 22, 2026 — classified as 1 injury, 37 malfunctions.
The most frequently reported specific device problem is “Break” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported INTUITION problems
Device problems
- Break15
- Device-Device Incompatibility9
- Material Deformation6
- Incorrect Measurement5
- No Apparent Adverse Event5
- Naturally Worn3
- Failure to Cut2
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- Insufficient Information3
- Bone Fracture(s)1
INTUITION models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INTUITION 2525-45-400TEMPLATE4 reports
- INTUITION 2525-45-005Orthopedic manual surgical instrument4 reports
- INTUITION 2525-50-000CHISEL, SURGICAL, MANUAL3 reports
- INTUITION 2525-50-002BIT, DRILL3 reports
- INTUITION 2525-10-011Orthopedic manual surgical instrument3 reports
- INTUITION 2525-30-400INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- INTUITION 2525-50-003DRIVER, PROSTHESIS2 reports
- INTUITION 2525-40-000INSTRUMENT, CUTTING, ORTHOPEDIC2 reports
- INTUITION 2525-10-100INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-30-100INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-30-200INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-31-200INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-30-300INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-31-300INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-31-400INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-30-500INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-10-006Orthopedic manual surgical instrument1 report
- INTUITION 2525-20-001INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-20-100INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-20-000INSTRUMENT, CUTTING, ORTHOPEDIC1 report
- INTUITION 2525-45-700BIT, DRILL1 report
- INTUITION 2525-40-300TEMPLATE1 report
- INTUITION 2525-41-400TEMPLATE1 report
Recent INTUITION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
It was reported that the UNI TIBIAL STYLUS spring was broken.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 50853049 ↗MalfunctionSep 10, 2026Break; Device-Device Incompatibility
It was reported that during a procedure, the short threaded headed pin sheared off when pinning the posterior cutting block from Sigma partial instrumentation. It was unable to be removed. No delay to surgery or harm to patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715191 ↗MalfunctionAug 18, 2026Break
It was reported that the bit was broken. There was no surgery delay and no patient affected but the sets now were useless.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50309227 ↗MalfunctionJun 30, 2026Unintended Movement
IT WAS REPORTED THAT THE DRILL DOES NOT RUN SMOOTHLY. IT IS WOBBLY. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666036 ↗MalfunctionJun 30, 2026Unintended Movement
IT WAS REPORTED THAT THE DRILL DOES NOT RUN SMOOTHLY. IT IS WOBBLY. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666029 ↗MalfunctionMay 13, 2026Mechanical Jam
THE SIGMA PARTIAL INSTRUMENT SET WAS OPENED BY THE THEATRE STAFF BY MISTAKE FOR THE 1ST CASE. THE SALES REPRESENTATIVE THEN PROCEEDED TO USE THE INSTRUMENTS FOR A DEMONSTRATION BEFORE OPENING THE 2ND SET FOR THE 3RD PATIENT ON THE LIST. THE TIBIAL STYLUS WAS JAMMED INTO A FIXED POSITION AND IT WAS IMPOSSIBLE TO ROTATE FROM SLOTTED TO NON-SLOTTED, AND USE EITHER THE 4MM OF 7MM RESECTION ENDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25161740 ↗MalfunctionApr 20, 2026Break
IT WAS REPORTED THAT THE INSERT USED FOR UNICOMPARTMENTAL KNEE ARTHROPLASTY OF THE RIGHT MEDIAL OR LATERAL LATERAL/LATERAL (UKA RM/LL) WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927345 ↗MalfunctionMar 10, 2026Break; Material Deformation
IT WAS REPORTED THAT THE SIZE 3 TIBIAL PREP TRAY PIN HOLE HAS BEEN DAMAGED. THE THREADED PIN CROSS THREADED, CAUSING SOME METAL PARTICLE DEBRIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560877 ↗MalfunctionFeb 11, 2026Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE FEMORAL AND THE TIBIA LUG DRILLS WERE BOTH SLIGHTLY SKEWED AND HAD A DIFFICULT TIME DRILLING THE HOLES, THE ADAPTER PIECE WORKED FINE WITH ALL OTHER INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317739 ↗MalfunctionFeb 11, 2026Failure to Cut; Material Deformation
IT WAS REPORTED THAT THE FEMORAL AND THE TIBIA LUG DRILLS WERE BOTH SLIGHTLY SKEWED AND HAD A DIFFICULT TIME DRILLING THE HOLES, THE ADAPTER PIECE WORKED FINE WITH ALL OTHER INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317732 ↗MalfunctionFeb 3, 2026Break; Improper or Incorrect Procedure or Method; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THE HP UNI FEM FINISH BLK SZ5 LMRL HAS ONE BROKEN FRAGMENT THAT IS STUCK ON THE MATING COMPONENT. THE HP UNI FEMORAL CHISEL IS ALSO ONE STUCK ON THE MATING COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24248210 ↗MalfunctionJan 26, 2026Break
IT WAS REPORTED THAT DURING INTRAOPERATIVE MEASUREMENT THE SMALL SPRING OF THE HPUNI TIB STYLUS WAS FOUND BROKEN INTO TWO PIECES. ALL FRAGMENTS WERE RETRIEVED, AND THERE WERE NO PATIENT ADVERSE CONSEQUENCES. THE SURGEON REQUIRED APPROXIMATELY TWO ADDITIONAL MINUTES TO COMPLETE TIBIAL CUTTING MEASUREMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24181734 ↗MalfunctionDec 13, 2025Device-Device Incompatibility; Device-Device Incompatibility
SIGMA HP UNI CUTTING BLOCK LEFT. THE PIN GOT STUCK DURING SURGERY IN THE BLOCK. NO ISSUE FOR THE PATIENT. SURGERY DELAY 2-5 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23797647 ↗MalfunctionNov 11, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE STYLUS IS FIXED IN ONE POSITION AND WILL NOT ROTATE IN ANY DIRECTION. THE STYLUS 4MM-7MM IS FIXED AND A PARTICULAR DIRECTION AND CANNOT BE ALTERED FROM TO SLOTTED TO NON-SLOTTED, THE PATIENT WASN¿T HARMED. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. EVENT OUTCOME/HOW WAS IT MANAGED? ANOTHER TRAY WAS USED. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO HARM TO THE PATIENT. WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM - HOW MANY MINUTES DELAY. 5 MINUTES EXTRA TO EACH CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526822 ↗MalfunctionJul 25, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT THE TRIAL INSERT CRACKED WHILE BEING REMOVED. NO DELAY IN CASE. THE PIECE THAT BROKE OFF WAS THROWN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22616933 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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