S-ROM 2576-22-115Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 22 D LARGE · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295146919), received between Sep 29, 2017 and Mar 23, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Illegible Information” (3 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 Information3
- Insufficient Device Problem Information2
- Material Deformation1
- Material Discolored1
- Material Twisted/Bent1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 5 most recent of 5 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 24668612 ↗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 9928308 ↗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 8466338 ↗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 7103841 ↗MalfunctionSep 29, 2017Insufficient Device Problem Information; Illegible Information; Insufficient Device Problem Information; Illegible Information
IT WAS REPORTED THAT THE ZT TRIAL SLEEVES ETCHING COMING OFF. IT WAS FOUND IN THE OFFICE SET.
Patient problems: No Code Available
MAUDE report 6903600 ↗
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.
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