S-ROM 2576-16-115Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 16 D LARGE · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295146452), received between Jul 21, 2017 and Apr 20, 2026 — classified as 22 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
- Scratched Material7
- Appropriate Device Problem Term/Code Not Available6
- Naturally Worn5
- Material Twisted/Bent3
- Device Markings/Labelling Problem2
- Device-Device Incompatibility2
- No Apparent Adverse Event2
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions5
- No Information5
- Insufficient Information1
Recent adverse event reports
The 22 most recent of 22 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 24927796 ↗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 24909996 ↗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 24681552 ↗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 22553534 ↗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 17219420 ↗MalfunctionMay 25, 2021Scratched Material; Scratched Material
IT WAS REPORTED AS "INSTRUMENTS WERE USED IN SURGERY. UPON INSPECTION OF THOSE INSTRUMENTS THIS MORNING, APRIL 29TH, WE NOTICED SOME DEFECTS IN THE TWO SLEEVE TRIALS MAKING IT DIFFICULT TO USE WITH THE "SLEEVE INTRODUCER" HANDLE. WE ALSO INSPECTED THE REAMER HANDLE AND IT WAS DIFFICULT TO LOCK ON THE CONICAL REAMERS. THESE ISSUES WERE NOT MENTIONED IN SURGERY, HOWEVER, AFTER SPEAKING WITH THE SURGICAL TECH TODAY, APRIL 29TH, HE ASKED ME TO TAKE A LOOK." NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11875901 ↗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 10002008 ↗MalfunctionApr 6, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT THE SROM SLEEVES ARE DAMAGED AND CAN¿T BE READ. NO LOT NUMBERS CAN BE READ. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9928309 ↗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 9912545 ↗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 9912533 ↗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 9765933 ↗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 9752884 ↗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 8466255 ↗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 8466232 ↗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 8361717 ↗MalfunctionApr 18, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SROM SLEEVES HAVE BECOME WORN FROM SAWING AND NEED REPLACEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7439532 ↗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 7421469 ↗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 6903459 ↗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 6903450 ↗MalfunctionSep 29, 2017Appropriate Device Problem Term/Code Not Available; Illegible Information; Appropriate Device Problem Term/Code Not Available; Illegible Information
IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.
Patient problems: No Information
MAUDE report 6903431 ↗MalfunctionAug 18, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE SROM SLEEVE TRIAL IS DAMAGED ON THE UNDERSIDE OF THE SLEEVE CAUSING IT TO BE DIFFICULT TO REMOVE WITH THE SLEEVE EXTRACTOR.
Patient problems: No Information
MAUDE report 6805090 ↗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 6731273 ↗
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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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