S-ROM 53-2029Recalls & reported problems
Depuy (Ireland) · S-ROM HIP STEM IMPACTOR/ROTATOR · Class 1
All models of S-ROM (185)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295171607), received between Jun 24, 2019 and Feb 13, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Device-Device Incompatibility3
- Contamination /Decontamination Problem1
- Corroded1
- Entrapment of Device1
- Naturally Worn1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE STEM INTRODUCER HANDLE WAS LOOSE AND COULD NO LONGER ROTATE THE STEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334538 ↗MalfunctionJul 17, 2025Break; Break
IT WAS REPORTED THAT THE ITEMS WERE BROKEN ON AN UNKNOWN DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529313 ↗MalfunctionMay 28, 2024Break; Break
IT WAS REPORTED THAT THE INSERTER TIP BROKE OFF. THE PENCIL TIP WAS BENT.
Patient problems: Insufficient Information
MAUDE report 19404126 ↗MalfunctionJan 30, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE STEM INSERTER NO LONGER SLIDES UP AND DOWN. METAL PIECE THAT ALLOWS THAT HAS FRAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16265194 ↗MalfunctionJul 14, 2022Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE HOSPITAL RECEIVED DIRTY INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15014376 ↗MalfunctionApr 7, 2022Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT THE HANDLE BROKE WHILE INSERTING THE STEM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14042714 ↗MalfunctionFeb 9, 2021Break; Break
BROKEN SROM INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11302049 ↗MalfunctionFeb 25, 2020Break; Break
IT WAS REPORTED THAT THE INSERTER TIP BROKE AND NEEDS REPLACEMENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9750745 ↗MalfunctionJun 24, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL BIT FOR ACETABULAR SCREWS BROKE DURING USE. FINAL SROM STEM INSERTER STUCK TO IMPLANT AND HAD TO BE PRIED OFF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8726481 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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