S-ROM 2576-36-008Recalls & reported problems
Depuy Orthopaedics, Inc. · S-ROM NECK TRIAL 36 STD +8 LAT · Class 1
All models of S-ROM (92)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295147077), received between Jan 24, 2018 and Nov 5, 2024 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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
- Device-Device Incompatibility9
- Illegible Information5
- Naturally Worn5
- Scratched Material4
- Material Twisted/Bent3
- Material Deformation2
- Connection Problem1
- Device Damaged by Another Device1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
- No Code Available1
- Not Applicable1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NECK SEGMENTS DOES NOT SCREW INTO STEM PROPERLY. THERE WAS NO ADVERSE CONSEQUENCE AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613338 ↗MalfunctionSep 12, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT 36+8 SROM NECK TRIAL WILL NOT PROPERLY THREAD ON TO THE STEM TRIAL. THREADS APPEAR TO BE WORN OR STRIPPED. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17729012 ↗MalfunctionJul 6, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NECK NO LONGER TIGHTENS DOWN ON THE STEM, OTHER NECKS WORK ON THE STEM BUT THIS ONE DOESN'T WORK ON ANY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14935322 ↗MalfunctionFeb 21, 2022Device-Device Incompatibility; Device-Device Incompatibility
NECK TRIAL WOULD NOT CONNECT TO THE STEM TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13574058 ↗MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIAL NECK DOESN¿T LOCK DOWN TO THE STEM. BOTH THE STEM AND NECK HAVE BEEN REQUESTED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12557709 ↗MalfunctionJul 9, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE NECK TRIAL IS STRIPPED. SURGEON COULD NOT GET THE NECK TRIAL TO LOCK DOWN TO THE STEM TRIAL. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12145497 ↗MalfunctionMar 25, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NECK TRIALS NO LONGER ATTACH TO THE STEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11570724 ↗MalfunctionApr 23, 2020Material Twisted/Bent; Naturally Worn; Illegible Information; Material Twisted/Bent; Naturally Worn; Illegible Information
IT WAS REPORTED THAT THESE INSTRUMENTS HAVE EXCESSIVE WEAR AND ARE DIFFICULT TO READ. REP INDICATED "THAT THEY NEED TO BE REPLACED". NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9992124 ↗MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9919387 ↗MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9919386 ↗MalfunctionApr 3, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENTS ARE SCRATCHED UP OR DAMAGED AND SIZES CAN¿T BE READ OR IDENTIFIED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9919385 ↗MalfunctionFeb 19, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information; Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE INSTRUMENT WERE DIFFICULT OR IMPOSSIBLE TO READ ETCHING DUE TO WEAR AND TEAR OVER THE YEARS. THE SURGEON IS CONCERNED ABOUT THE PATIENT SAFETY ISSUE AND THE INSTRUMENTS NEED TO BE REPLACED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 9729053 ↗MalfunctionJan 23, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SROM MACH 1 36+8 LAT NECK TRIAL ITEM WILL NOT LOCK DOWN TIGHTLY ON TRIAL BODY - POSSIBLY DAMAGED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9624942 ↗MalfunctionJul 1, 2019Device-Device Incompatibility; Device-Device Incompatibility
THREAD ON THE INSIDE OF THE S-ROM 36+8 NECK TRIAL WAS FAULTY AND WOULDN'T ENGAGE WITH THE STEM TRIAL.
Patient problems: Not Applicable
MAUDE report 8750480 ↗MalfunctionJan 8, 2019Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SROM 36+8 TRIAL NECK IS STRIPPED AND WON'T TIGHTEN DOWN ON TRIAL STEM. NEEDS REPLACING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8227446 ↗MalfunctionAug 21, 2018Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE TRIAL 15MM STEM AND THE 36+8 NECK SEGMENT ARE BOTH STRIPPED AND WOULD NOT ENGAGE. THE STEM/SLEEVE WEDGES DAMAGED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7802426 ↗MalfunctionMar 23, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE 36+8 TRIAL NECK ON SROM WILL NOT TIGHTEN PROPERLY. NO PIECES BROKEN AND NO PATIENT INVOLVEMENT. NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7365127 ↗MalfunctionJan 24, 2018Connection Problem; Material Deformation; Connection Problem; Material Deformation
IT WAS REPORTED THAT THE THREADS ON 36STD+8LAT NECK TRIAL ARE STRIPPED. NEEDS REPLACING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7217004 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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