S-ROM 2576-13-100Recalls & reported problems
Depuy (Ireland) · S-ROM DISTAL STEM TRIAL, STANDARD SIZE 13 · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy S-ROM trial stem is a sizing trial template. Reports mostly describe worn, scratched or bent pieces with damaged threads that do not fit tightly with the neck piece and markings that are hard to read. There are 26 reports that name its identifier, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295146193), received between Jul 21, 2017 and Apr 13, 2026 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 Incompatibility11
- Naturally Worn7
- Material Deformation6
- Illegible Information4
- Material Twisted/Bent4
- Scratched Material3
- Dull, Blunt2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient10
- Not Applicable3
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT UPON INSPECTION OF THE INSTRUMENTS AFTER SURGERY, THE REPORTER DISCOVERED THAT THE THREADS ON THE STEM BODY WERE DAMAGED AND WON'T PROPERLY CONNECT TO THE NECK TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24861500 ↗MalfunctionOct 22, 2025No Apparent Adverse Event; Illegible Information; No Apparent Adverse Event; Illegible Information
IT WAS REPORTED THAT THE SROM TRIALS ARE TOO WORN AND DIFFICULT TO READ. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23362456 ↗MalfunctionJul 25, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TRIALS STICK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610279 ↗MalfunctionSep 16, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT SROM TRIAL STEM THREADS WERE DAMAGED MAKING IT DIFFICULT TO TIGHTEN THE TRIAL NECK ONTO THE STEM. THE CASE WAS NOT DELAYED AND ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 20223745 ↗MalfunctionSep 6, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SROM TRIAL STEM THREADS ARE DAMAGED AND THE TRIAL NECK WOULD NOT TIGHTEN ONTO THE TRIAL STEM. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17691451 ↗MalfunctionApr 19, 2023Corroded; Corroded
DEVICES APPEAR RUSTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16767577 ↗MalfunctionDec 16, 2022Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PRODUCT WAS NOT USED. STERILE PROCESSING FOUND A LARGE GOUGE IN THE SIDE OF THE STEM AND REFUSED TO ACCEPT IT. THERE WAS NO REPORTED DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15995400 ↗MalfunctionOct 27, 2022Break; Break
THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. THERE WAS A SURGICAL DELAY REPORTED FOR 2 MINUTES.
Patient problems: Insufficient Information
MAUDE report 15680589 ↗MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE NECK TRIAL WOULD NOT SCREW IN TO THE STEM TRIAL. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15152015 ↗MalfunctionJul 12, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT BOTH THE NECK AND THE STEM WILL NOT LOCK TIGHTEN DOWN TOGETHER. THE NECK DOESN¿T WORK ON ANY OTHER STEM TRIAL AND THE STEM TRIAL WILL NOT TIGHTEN TO ANY NECK. BOTH NEED TO BE REPLACED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14985717 ↗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 12557687 ↗MalfunctionApr 13, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT WHILE SURGERY WAS TAKING PLACE, THE PRODUCTS LISTED BELOW WERE ALL TRIALED AND SHOWED SIGNS OF DYSFUNCTION. NEITHER THE BODIES OR THE STEMS WOULD FULLY LOCKED DOWN AND CONNECT TO EACH OTHER. SOME OF THE BODY SHOWED SIGNS OF THREADED THREADS. SURGERY WAS DELAYED. THERE WERE NO PARTS BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11657066 ↗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 9992127 ↗MalfunctionFeb 20, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT SROM INSTRUMENTS ARE DIFFICULT OR IMPOSSIBLE TO READ THE SIZING. SURGEON IS CONCERNED THIS IS A PATIENT SAFETY ISSUE AND INSTRUMENTS SHOULD BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9734655 ↗MalfunctionFeb 20, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; 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 Consequences Or Impact To Patient
MAUDE report 9732497 ↗MalfunctionMar 29, 2019Device-Device Incompatibility; Material Deformation; Scratched Material; Device-Device Incompatibility; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE 18X13 STEM TRIAL AND 18X13 36+12 NECK TRIAL DO NOT ENGAGE PROPERLY WHEN THREADED TOGETHER. BOTH NEED REPLACED. SURGICAL DELAY FOR 3 MINUTES.
Patient problems: Not Applicable
MAUDE report 8465455 ↗MalfunctionMar 26, 2019Device-Device Incompatibility; Material Deformation; Scratched Material; Device-Device Incompatibility; Material Deformation; Scratched Material
IT WAS REPORTED THAT THE STEM TRIAL WILL NO LONGER ACCEPT A NECK SEGMENT TO LOCK DOWN TO CREATE A TRIAL. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8453025 ↗MalfunctionFeb 11, 2019Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT THE TOP SPLINES ON THE 18X13 SROM MACH-1 STEM TRIAL STRIPPED OFF, PREVENTING THE TRIAL NECK TO ENGAGE WITH THE TRIAL STEM.
Patient problems: Not Applicable
MAUDE report 8325995 ↗MalfunctionJan 29, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SLEEVE INTRODUCER WILL NOT STAY LOCKED WHEN THE HANDLE IS BEING EXTRACTED. ALSO, 18X13 STEM TRIAL AND 36+12 NECK HAS BAD THREADS.
Patient problems: Not Applicable
MAUDE report 8285756 ↗MalfunctionOct 29, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE S-ROM STEM HAS DIFFICULTY CONNECTING TO ANY S-ROM NECK SEGMENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8014141 ↗MalfunctionJul 13, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TRIALS NO LONGER ENGAGE THE NECK SEGMENTS. THE THREADS MAY BE DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7685074 ↗MalfunctionJul 13, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE TRIALS NO LONGER ENGAGE THE NECK SEGMENTS. THE THREADS MAY BE DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7685063 ↗MalfunctionJul 13, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SROM STEM TRIAL THREADS WERE DAMAGED AND THE TRIAL NECK WOULD NOT ENGAGE PROPERLY. THE SURGERY WAS NOT DELAYED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7684916 ↗MalfunctionMay 1, 2018Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn
WARRINGAL PRIVATE (B)(6) 2018 THREAD STRIPPED -PRODUCT CODE D2576134100 - 18X13 TRIAL STEM, UNKNOWN LOT #.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7475178 ↗MalfunctionJan 4, 2018Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn
IT WAS REPORTED THAT THE SROM 13X18 STEM TRIAL WAS STRIPPED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7164016 ↗
Other TEMPLATE devices
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- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
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- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 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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