S-ROM 2576-09-104Recalls & reported problems
Depuy (Ireland) · S-ROM DISTAL STEM TRIAL, LONG - BOWED SIZE 9 · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295146032), received between Aug 4, 2020 and Aug 4, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Entrapment of Device1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2020Break; Entrapment of Device; Break; Entrapment of Device
STEM TRIAL BROKE DURING TRIAL REDUCTION. UNSUCCESSFULLY TRIED TO RETRIEVE BROKEN PART FROM PATIENTS FEMORAL CANAL. REAMED CANAL PUSHING BROKEN PIECE DOWN CANAL AND OUT OF WAY TO COMPLETE THA. BROKEN PIECE OF STEM REMAINED IN PATIENT. CUSTOMER REFERENCE/PO/SERVICE: (B)(6) HOSPITAL, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 20 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? ATTEMPTED TO RETRIEVE BROKEN PIECE BUT UNSUCCESSFUL. PUSHED DOWN FEMORAL CANAL WITH REAMER IN ORDER TO COMPLETE SUCCESSFUL THA. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, IF NO, EXPLAIN --> COULD NOT RETRIEVE BROKEN PIECE. REMAINS IN PATIENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: X-RAY NEEDED TO CONFIRM BROKEN PIECE WAS STILL IN FEMORAL CANAL, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSE
Patient problems: No Code Available
MAUDE report 10363167 ↗
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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