S-ROM 2576-16-110Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 16 D SMALL · Class 1
All models of S-ROM (185)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy S-ROM trial sleeve is a sizing piece used during hip surgery. Reports mostly describe worn or scratched trials with markings that are hard to read, and pieces that do not fit or release easily from their instruments. There are 25 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
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295146445), received between Jul 21, 2017 and Jun 5, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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
- Device-Device Incompatibility7
- Naturally Worn7
- Scratched Material6
- Break4
- Illegible Information4
- Material Twisted/Bent4
- Appropriate Device Problem Term/Code Not Available3
- No Apparent Adverse Event3
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient9
- No Information3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE SROM TRIALS ARE TOO SCRATCHED AND DIFFICULT TO READ THE SIZES. ALSO THE OFFSET REAMER HANDLE STOPPED WORKING. FINISHED WITH A DIFFERENT REAMER. NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409426 ↗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 24927793 ↗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 24909888 ↗MalfunctionMar 5, 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 24522591 ↗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 22553547 ↗MalfunctionJun 27, 2025Break; Break
IT WAS REPORTED THAT THE IMPLANT BROKE DURING HIP SURGERY. THIS DID NOT DELAY SURGERY, AND NOTHING WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346200 ↗MalfunctionJun 5, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE TRIAL WAS MARRED UP SO MUCH AT THE BOTTOM THAT THE EXTRACTOR CANNOT GRAB IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148668 ↗MalfunctionSep 27, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SLEEVE TRIAL WOULD NOT FIT ONTO THE SLEEVE INSERTER PROPERLY. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17824269 ↗MalfunctionJun 29, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT SLEEVE TRIALS ARE DAMAGED AND NO LONGER FIT ON ¿SLEEVE INTRODUCER¿. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224298 ↗MalfunctionJun 28, 2023Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THERE WAS SOME METAL CHIPPED ON BOTH OF THE SROM SLEEVE TRIALS PREVENTING THE STEM TO FULLY SEAT THROUGH THE SLEEVE TRIALS.
Patient problems: Insufficient Information
MAUDE report 17219427 ↗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 14675172 ↗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 14674579 ↗MalfunctionNov 4, 2021Device-Device Incompatibility; Device-Device Incompatibility
TRIAL SLEEVE WOULD STICK TO TRIAL SLEEVE INSERTER HANDLE AFTER BEING IMPACTED. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751136 ↗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 9752913 ↗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 9226290 ↗MalfunctionSep 24, 2019Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING SURGERY. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9109461 ↗MalfunctionApr 2, 2019Break; Material Twisted/Bent; Positioning Problem; Break; Material Twisted/Bent; Positioning Problem
IT WAS REPORTED THAT BOTH INSTRUMENTS WERE NOTICED AS BEING DEFECTIVE BEFORE THEY WERE TURNED INTO STERILE PROCESSING. THE SLEEVE IS BENT AND WOULD NOT CORRECTLY FIT ON THE SLEEVE INTRODUCER (ANOTHER INSTRUMENT IN THE S-ROM TRAYS). THESE HAD NO EFFECT ON SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8475773 ↗MalfunctionMar 29, 2019Material Discolored; Material Deformation; Material Twisted/Bent; Naturally Worn; Scratched Material; Material Discolored; Material Deformation; Material Twisted/Bent; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE OFFICE SETS INSTRUMENT WAS WORN AND CANNOT READ. NO SURGERY WAS AFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466334 ↗MalfunctionMar 29, 2019Device Markings/Labelling Problem; Naturally Worn; Scratched Material; Device Markings/Labelling Problem; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN OUT AND CANNOT READ ETCHING. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466218 ↗MalfunctionMar 29, 2019Device Markings/Labelling Problem; Naturally Worn; Scratched Material; Device Markings/Labelling Problem; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE OFFICE SETS WERE WORN OUT AND CANNOT READ ETCHING. DID NOT EFFECT A SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466213 ↗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 8361707 ↗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 7104312 ↗MalfunctionSep 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.
Patient problems: No Information
MAUDE report 6903907 ↗MalfunctionSep 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.
Patient problems: No Information
MAUDE report 6903864 ↗MalfunctionJul 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT UPON POST-SURGICAL INSPECTION OF INSTRUMENT PANS, IT WAS DISCOVERED THAT SOME OF THE SLEEVES WERE CHIPPED AWAY TO WHERE DEBRIS COULD BE A CONCERN DURING TRIALING.
Patient problems: No Information
MAUDE report 6731275 ↗
Other TEMPLATE devices
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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