S-ROM 2576-18-100Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 18 B SMALL · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295146582), received between Dec 11, 2017 and Apr 20, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (8 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
- Illegible Information8
- Naturally Worn8
- Device-Device Incompatibility4
- Material Deformation4
- Material Twisted/Bent4
- Scratched Material4
- No Apparent Adverse Event3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient11
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
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 24927795 ↗MalfunctionApr 17, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THESE INSTRUMENTS HAVE REACHED END OF LIFE. THE SURGEONS HAVE CONTINUALLY COMPLAINED ABOUT WEAR AND TEAR OF INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910496 ↗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 24675619 ↗MalfunctionOct 21, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT EXTRACTING THE TRIAL WAS DIFFICULT BECAUSE THE BOTTOM IS ALL CHEWED UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349688 ↗MalfunctionJun 12, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP REPLACEMENT ON (B)(6) 2025. THE SLEEVE TRIAL WAS WARPED AT THE BOTTOM MAKING IT DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193999 ↗MalfunctionApr 8, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT WHILE TRYING TO REMOVE THE SLEEVE TRIAL, IT WAS DISCOVERED THAT THE SLEEVE WAS WORN OUT WHERE THE SLEEVE EXTRACTION INSTRUMENT SHOULD CATCH. NO TIME ADDED TO CASE. NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19059800 ↗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 17020950 ↗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 16412964 ↗MalfunctionJul 26, 2022No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE NOT EASILY EXTRACTED FROM FEMUR FOR REPEATED USE AND WEAR. SURGEON HAS REQUESTED THEY BE REPLACED. LOT NUMBERS NOT AVAILABLE DUE TO WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15104628 ↗MalfunctionJun 13, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE NOT EASILY EXTRACTED FROM FEMUR FOR REPEATED USE AND WEAR. SURGEON HAS REQUESTED THEY BE REPLACED. LOT NUMBERS NOT AVAILABLE DUE TO WEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14675379 ↗MalfunctionJun 13, 2022Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE GETTING STUCK IN THE FEMUR AND NOT EASILY EXTRACTED DUE TO REPEATED USE. SURGEON REQUESTED THEY BE REPLACED. LOT NUMBERS ARE NOT LEGIBLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14675019 ↗MalfunctionJun 13, 2022Break; Naturally Worn; Illegible Information; Break; Naturally Worn; Illegible Information
IT WAS REPORTED THAT TRIAL SLEEVE IS DIFFICULT TO EXTRACT DUE TO REPEATED USE. MATERIAL HAS BEEN CHIPPED AND PRODUCT ETCHINGS ARE ILLEGIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674517 ↗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 9912528 ↗MalfunctionFeb 27, 2020Material Twisted/Bent; Scratched Material; Illegible Information; Material Twisted/Bent; Scratched Material; 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 9765934 ↗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 9752897 ↗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 9226287 ↗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 9226286 ↗MalfunctionSep 12, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT THE SLEEVES TRIALS HAVE BENT THE EDGE AROUND THE BOTTOM AND THE SLEEVE EXTRACTOR DOESN'T HAVE ANYTHING TO GRAB ON TO. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9010392 ↗MalfunctionApr 3, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
CSSD ALSO REPORTED SOME CHIPPING AND BENT PORTIONS OF THE SROM TRIAL SLEEVES. IF OTHER, DESCRIBE --> CSSD STAFF REPORTED NOTICING AFTER STERILIZING INSTRUMENTS., PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8479775 ↗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 8466269 ↗MalfunctionNov 27, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SLEEVE IS STARTING TO NARROW OUT AROUND THE BOTTOM EDGE AND IS HARD TO REMOVE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8105746 ↗MalfunctionApr 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT POST CLEANING INSPECTION SHOWED DAMAGE TO IDENTIFYING MARKINGS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7421476 ↗MalfunctionDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT ALL OF THE 10 SROM INSTRUMENTS WERE DEEMED TO BE UNUSABLE BECAUSE THE SIZE MARKINGS ARE NO LONGER VISIBLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7104340 ↗
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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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