INTUITION 2525-10-011Recalls & reported problems
Depuy (Ireland) · INTUITION FOR HP PARTIAL TIBIAL INSERT TRIAL SIZE 3 7mm · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295544807), received between Jan 10, 2025 and Aug 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionJan 10, 2025Break; Break
IT WAS REPORTED THAT THE INSERT TRIAL BROKE WHILE BEING REMOVED INTRAOPERATIVELY PER SURGICAL TECHNIQUE.
Patient problems: Insufficient Information
MAUDE report 21122998 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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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