S-ROM 2576-18-115Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 18 D LARGE · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295146612), received between Sep 29, 2017 and Apr 28, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (10 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 Information10
- Appropriate Device Problem Term/Code Not Available4
- Naturally Worn2
- No Apparent Adverse Event2
- Scratched Material2
- Display Difficult to Read1
- Insufficient Device Problem Information1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions6
- No Information3
Recent adverse event reports
The 17 most recent of 17 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 25015144 ↗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 24927803 ↗MalfunctionMar 23, 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 24664982 ↗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 24522274 ↗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 24521991 ↗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 14674438 ↗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 9919357 ↗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 9919355 ↗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 9752903 ↗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 8466254 ↗MalfunctionMay 7, 2018Material Deformation; Material Deformation
DURING SURGERY, SURGEON AND SURGICAL TECHS REFERENCES THAT SOME OF THE INSTRUMENTS WERE DAMAGED FROM USE OVER THE YEARS, AND DIFFICULT TO READ. THEY ASKED THAT IT WOULD BE NICE TO GET THEM REPLACED. NO ADDITIONAL TIME WAS ADDED TO THIS CASE AS RESULT TO THEIR COMPLAINTS. NO COMPLICATIONS OCCURRED DUE TO THE INSTRUMENTS. PRODUCT WILL BE SHIPPED BACK ONCE HOSPITAL RECEIVES REPLACEMENT PLEASE SHIP REPLACEMENT TO (B)(6). PATIENT CONSEQUENCE? NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7490076 ↗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 7439487 ↗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 7421490 ↗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 7104128 ↗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 6903519 ↗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 6903488 ↗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 6903475 ↗
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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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