S-ROM 87-5962Recalls & reported problems
Depuy (Ireland) · S-ROM FEMORAL HEAD TRIAL 11/13 TAPER 32mm +3mm · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295218890), received between Feb 19, 2020 and Jan 27, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
- Naturally Worn1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TRIAL HEADS SHOW SIGNIFICANT WEAR DUE TO MULTIPLE USES AND NEED TO BE REPLACED. THE SALES REP BECAME AWARE OF THIS ON (B)(6) 2023, WHILE SETTING UP FOR THE PROCEDURE. FOUND TEMPORARY REPLACEMENTS FOR THIS SURGERY. LOT NUMBER COULD NOT BE READ ON THE 32MM +0. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16253496 ↗MalfunctionFeb 19, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material
CALL FROM THE HOSPITAL TO REPLACE 3 INSTRUMENTS DUE TO WEAR AND TEAR. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9728675 ↗
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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