N/A 96-6876Recalls & reported problems
Depuy (Ireland) · UNIVERSAL PRESS-FIT STEM TRIAL 14mm x 75mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295496427), received between May 21, 2020 and Oct 21, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Reports received per month
Most reported problems
Device problems
- Break6
- Device-Device Incompatibility1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT WAS DISCOVERED DURING INTRA-OP.
Patient problems: Insufficient Information
MAUDE report 20492332 ↗MalfunctionFeb 1, 2024Break; Break
IT WAS REPORTED THAT THE SMALL NOSES OF TRIAL EXTENSIONS ARE BROKEN OFF. NO PATIENT HARM. NO SURGERY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18627359 ↗MalfunctionJun 17, 2022Break; Break
IT WAS REPORTED THAT THE TABS WERE SHEERED OFF OF THE TRIAL. ALL PIECES WERE RETRIEVED. ANOTHER TRIAL SET USED TO COMPLETED THE CASE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14733960 ↗MalfunctionApr 29, 2022Break; Break
IT WAS REPORTED THAT THE TABS ON 14X75 PILOT SHAFT WAS BROKE. ALL PIECES WERE RETRIEVED. MBT SIZE 4 CLEAR TRIAL BROKE W/WEAR. NO PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14251760 ↗MalfunctionJul 8, 2020Break; Entrapment of Device; Break; Entrapment of Device
TWO SMALL PIECES OF INSTRUMENT BROKE AND REMAIN IN THE PATIENT TIBIA CANAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10245907 ↗MalfunctionMay 21, 2020Break; Break
IT WAS REPORTED THAT THE REAMER END STRIPPED AS SURGEON WAS DOING THE CASE. THE STEM TRIAL ATTACHMENT NUBS BROKE OFF AS SURGEON WAS PREPPING THE TIBIAL SLEEVE. SURGICAL DELAY 10 MINUTES.
Patient problems: No Code Available
MAUDE report 10080412 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- 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
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page