INTUITION 2525-50-000Recalls & reported problems
Depuy (Ireland) · INTUITION FOR HP PARTIAL FEMORAL CHISEL · Class 1
All models of INTUITION (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295544630), received between Sep 17, 2024 and May 5, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Incorrect Measurement1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Incorrect Measurement; No Apparent Adverse Event; Incorrect Measurement; No Apparent Adverse Event
IT WAS REPORTED THAT ON APRIL 11, 2025, THE PERSON IN CHARGE CHECKED THE PRODUCTS AND FOUND THAT THERE WERE DIFFERENCES BETWEEN THE PRODUCTS AND THE CAD MODELS. SPECIFICALLY, THE DIFFERENCES ARE AS FOLLOWS: CHISEL ACTUALLY GOES APPROXIMATELY 1MM DEEPER THAN IT¿S OBSERVED IN NX MODELS FOR ALL FINISHING GUIDES LM SZ 1-4 ON MY END. SIZE 2 LM SHOWN BELOW. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21963245 ↗MalfunctionApr 22, 2025Break; Break
IT WAS REPORTED THAT TWO INSTRUMENTS WERE BROKEN. THE CUTTING BLOCK WAS NOT WORKING ANYMORE; IT SEEMS THE ANTERIOR CHISEL PLACE IS NOT FUNCTIONING. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885124 ↗InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INTRA OPERATIVE MEDIAL CONDYLE FRACTURE WITH UNITY ANTERIOR CHISEL.
Patient problems: Bone Fracture(s)
MAUDE report 20236978 ↗
Other CHISEL, SURGICAL, MANUAL devices
- SIGMA 2024-85-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL63 reports
- NA 2421-01-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL36 reports
- NA 399.56Synthes GmbH · CHISEL, SURGICAL, MANUAL11 reports
- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
- NA 332.121Synthes GmbH · CHISEL, SURGICAL, MANUAL5 reports
- INSTRUMENT 6541-4-709Howmedica Osteonics Corp. · CHISEL, SURGICAL, MANUAL4 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 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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