S-ROM 2365-32-500Recalls & reported problems
Depuy (Ireland) · S-ROM TRIAL HEAD 36mm +3 · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295120049), received between Aug 21, 2017 and Feb 16, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
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
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Illegible Information1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2023Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
IT WAS REPORTED THE TRIAL WOULD NOT STAY ON THE NECK TRIAL. NO SURGICAL DELAY WAS THERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16385873 ↗MalfunctionAug 8, 2018Scratched Material; Scratched Material
GENERAL WEAR, SCRATCHES ON HEAD MAKING IT DIFFICULT TO READ.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7761466 ↗MalfunctionAug 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT HEAD TRIALS WERE FOUND TO HAVE DEEP GOUGES UPON POST SURGICAL OBSERVATION. IT WAS ALSO STATED THAT THE SURFACES ARE DAMAGED.
Patient problems: No Information
MAUDE report 6808335 ↗
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