N/A 96-6875Recalls & reported problems
Depuy (Ireland) · UNIVERSAL PRESS-FIT STEM TRIAL 12mm x 75mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295496410), received between Apr 8, 2019 and Aug 30, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 30, 2023Break; Break
IT WAS REPORTED THAT THE 75*12 UNIVERSAL STEM TRIAL TABS BROKE OFF. ALL PIECES RETRIEVED. NO DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 17656494 ↗MalfunctionApr 8, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE METAL CONNECTION PIECES OF THE 75X12 STEM TRIAL ARE BROKEN AND WILL NOT ATTACH TO THE BROACH. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8490997 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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