S-ROM 2576-20-125Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 20 F LARGE · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295146780), received between Sep 29, 2017 and Mar 23, 2026 — classified as 11 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
- Appropriate Device Problem Term/Code Not Available3
- Naturally Worn3
- Break2
- Material Twisted/Bent2
- Scratched Material2
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient7
- No Clinical Signs, Symptoms or Conditions2
- No Information2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026Illegible Information
IT WAS REPORTED THAT THE TOPS OF THE SLEEVE TRIALS HAVE THE SIZES SCRAPED OFF. THIS DID NOT OCCUR INTRAOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24665457 ↗MalfunctionJul 8, 2024Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THE PIECE WAS DEFORMED WHICH MADE IT DIFFICULT TO REMOVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19691798 ↗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 10002014 ↗MalfunctionApr 6, 2020Break; Illegible Information; Break; Illegible Information
IT WAS REPORTED THAT INSTRUMENTS ARE BROKEN AND CAN¿T BE READ.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929207 ↗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 9928315 ↗MalfunctionFeb 27, 2020Material Twisted/Bent; Naturally Worn; Scratched Material; Illegible Information; Material Twisted/Bent; Naturally Worn; 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9765288 ↗MalfunctionFeb 25, 2020Naturally Worn; Scratched Material; Illegible Information; Naturally Worn; Scratched Material; 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 9752084 ↗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 7439657 ↗MalfunctionApr 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT IDENTIFYING MARKINGS FOUND TO BE DAMAGED IN POST CLEANING INSPECTION, IT IS UNREADABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7421573 ↗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 6903656 ↗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 6903641 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page