S-ROM 2576-18-110Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 18 D SMALL · 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 sleeve is used to size the hip implant during hip replacement surgery. The 30 reports mostly describe instruments wearing out after long service — size markings scratched off or too worn to read, sleeves bent, chipped or deformed, and a few that would not release easily from the sleeve introducer. Most mention no effect on the patient and no surgical delay. No deaths or injuries are reported, and 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295146605), received between Sep 29, 2017 and Apr 28, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (12 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
- Naturally Worn12
- Illegible Information11
- Material Deformation6
- Appropriate Device Problem Term/Code Not Available4
- Scratched Material4
- Display Difficult to Read3
- Material Twisted/Bent3
- No Apparent Adverse Event2
Patient problems
- No Consequences Or Impact To Patient18
- No Clinical Signs, Symptoms or Conditions10
- No Information1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE SROM PRODUCTS BELOW HAVE REACHED END OF LIFE. THEY HAVE BEEN IN SERVICE FOR NEARLY 20 YEARS. THE SURGEON COMPLAINED THAT THE INSTRUMENTS ARE SO WORN, THEY ARE UNREADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25014998 ↗MalfunctionApr 20, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THESE PRODUCT HAD REACHED END OF LIFE DUE TO WEAR AND TEAR. THE SURGEONS COMPLAINED THAT INSTRUMENTS WERE DULL, ILLEGIBLE, AND GENERALLY WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927801 ↗MalfunctionMar 24, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681922 ↗MalfunctionMar 6, 2026Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE SROM TRIALS ARE TO SCRATCHED AND DIFFICULT TO READ THE SIZES. ALSO THE OFFSET REAMER HANDLE STOPPED WORKING. FINISHED WITH A DIFFERENT REAMER. THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530291 ↗MalfunctionJul 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING SURGERY, THEY FOUND SEVERAL OF THE SLEEVE TRIALS UNABLE TO EASILY DISENGAGE FROM THE SLEEVE INTRODUCER. THERE WAS NO DELAY IN THE SURGERY OR EXTENSION OF SURGERY TIME DUE TO THIS INCIDENT, AND THERE WERE NO COMPLICATIONS, BAD OUTCOMES, OR PATIENT HARM AS A RESULT OF THIS INCIDENT NEITHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553712 ↗MalfunctionMay 30, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THAT SLEEVE IS TOO DAMAGE TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020963 ↗MalfunctionFeb 21, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
IT WAS REPORTED THE BOTTOM OF THE TRIAL HAS BEEN WORN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16412924 ↗MalfunctionAug 9, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT BOTTOM OF SLEEVE TRIAL CHIPPED UPON EXTRACTION. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192981 ↗MalfunctionJun 13, 2022Illegible Information; Illegible Information
IT WAS REPORTED THAT THE TRIAL SLEEVE IS DIFFICULT TO EXTRACT AND THE LOT NUMBER IS ILLEGIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674419 ↗MalfunctionJun 2, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT SLEEVE BENT DURING EXTRACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14572252 ↗MalfunctionApr 27, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; 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 10002005 ↗MalfunctionApr 3, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED OR DAMAGED. NOT USED IN A CASE. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9919360 ↗MalfunctionApr 1, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SROM SLEEVES CAN¿T BE READ OR USED AND ARE DAMAGED. CAN¿T READ LOT NUMBERS SO DON¿T ASK FOR THEM. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9912542 ↗MalfunctionFeb 27, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE DIFFICULT TO IMPOSSIBLE TO READ SIZING DUE TO WEAR AND TEAR AND NORMAL EVERYDAY USE. THE NEED TO BE REPLACED SO THAT THE SURGEON IS ABLE TO SAFELY DETERMINE THE SIZE OF THE TRIAL BEING USED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9765932 ↗MalfunctionFeb 25, 2020Material Twisted/Bent; Illegible Information; Material Twisted/Bent; Illegible Information
IT WAS REPORTED THAT THE S-ROM SLEEVE TRIALS ARE EITHER DIFFICULT TO IMPOSSIBLE TO READ THE SIZE. THIS IS A SAFETY CONCERN FOR THE SURGEON WHO CAN'T EASILY DETERMINE THE SIZE OF THE TRIAL SLEEVE BEING INSERTED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9752886 ↗MalfunctionOct 23, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226289 ↗MalfunctionOct 23, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226284 ↗MalfunctionOct 23, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE SLEEVES TRIALS DISTAL EDGE HAS WORN AND CANNOT BE EXPLANTED EASILY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226277 ↗MalfunctionApr 5, 2019Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE TRIAL IS WORN OUT AND NOT BROKEN BUT IS NOT FUNCTIONING CORRECTLY AND NEEDS REPLACED. 15 MINUTES SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 8488171 ↗MalfunctionMar 29, 2019Display Difficult to Read; Naturally Worn; Display Difficult to Read; Naturally Worn
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN AND NOT ABLE TO READ. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466261 ↗MalfunctionMar 29, 2019Display Difficult to Read; Naturally Worn; Display Difficult to Read; Naturally Worn
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN AND NOT ABLE TO READ. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466258 ↗MalfunctionMar 29, 2019Display Difficult to Read; Naturally Worn; Display Difficult to Read; Naturally Worn
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN AND NOT ABLE TO READ. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466257 ↗MalfunctionMar 25, 2019Break; Break
REMOVING THE SROM SLEEVE IN HARD BONE WAS DAMAGED BY SLEEVE REMOVAL INSTRUMENT. FURTHER CLARIFICATION DETERMINED THAT THERE WAS A SMALL FRAGMENT THAT CAME OFF THE SLEEVE TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8449296 ↗MalfunctionFeb 22, 2019Material Discolored; Naturally Worn; Scratched Material; Material Discolored; Naturally Worn; Scratched Material
IT WAS REPORTED THAT INSTRUMENTS- SROM SLEEVE TRIAL WAS WORN AND CAN'T READ SIZING INFO ON THEM. 16D SMALL; 18B SMALL; 16D LARGE. BROKEN DRILL BIT. BROKE ON CUTTING FLUTES. 25MM. DRILL BIT HAD BEEN REUSED MULTIPLE TIMES. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8361718 ↗MalfunctionJun 4, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SROM TRIAL SLEEVE WAS DAMAGED AND NOW WILL NOT SEAT ON THE SLEEVE INTRODUCER OR THE TRIAL STEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7564862 ↗
Other TEMPLATE devices
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- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- 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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