S-ROM 2576-14-100Recalls & reported problems
Depuy (Ireland) · S-ROM ZT TRIAL SLEEVE SIZE 14 B SMALL · 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 10603295146278), received between Sep 8, 2017 and Sep 12, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Illegible Information2
- Material Deformation2
- Scratched Material2
- Device-Device Incompatibility1
- Naturally Worn1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT IS WORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15406657 ↗MalfunctionApr 9, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SLEEVE TRIALS ARE SCARRED UP AND SIZES CAN¿T BE READ. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9944162 ↗MalfunctionApr 9, 2020Scratched Material; Illegible Information; Scratched Material; Illegible Information
IT WAS REPORTED THAT THE SLEEVE TRIAL WAS SCARRED UP AND SIZES COULD NOT BE READ. THERE WAS NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9944159 ↗MalfunctionAug 8, 2019Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation
ADDITIONAL INFORMATION RECEIVED THAT THE INSTRUMENTS WERE BROKEN FROM THE BEGINNING OF THE SURGERY SO THEY DON'T KNOW WHEN IT HAPPENS. THE TEETH WERE STRIPPED. NOTHING WAS LEFT IN THIS PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8873452 ↗MalfunctionSep 8, 2017Break; Break
IT WAS REPORTED THAT THE 14B SLEEVE WAS DAMAGED DURING THE TRAILING PROCESS.
Patient problems: No Information
MAUDE report 6851244 ↗
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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