S-ROM 53-6314Recalls & reported problems
Depuy (Ireland) · S-ROM HIP STEM TRIAL BODY 14mm · Class 1
All models of S-ROM (185)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295172789), received between Aug 8, 2019 and Jan 12, 2026 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility2
- Detachment of Device or Device Component1
- Material Deformation1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Device-Device Incompatibility
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE, AFTER CLEANING OF THE DEVICE, IT WAS OBSERVED THAT THE DRILL SHAFT OF THE TRIAL DEVICE COULD NOT CONNECT WITH THE EQUIPMENT WHEN THE SURGEON PRACTICED ASSEMBLING THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24032032 ↗MalfunctionOct 23, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING HIP SURGERY. IT¿S VERY STIFF AND KEEPS GETTING STUCK. THERE WERE NO DELAYS TO SURGERY, NOTHING BROKE OFF OR WAS LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513294 ↗MalfunctionSep 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ADDITIONAL INFORMATION WAS RECEIVED: NO PATIENT CONSEQUENCE. NO SIGNS, SYMPTOMS OR PATIENT. FELL APART - UNATTACHED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20300750 ↗MalfunctionAug 8, 2019Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation
THE TRIALS AND THEIR TEETH WERE BROKEN TO THE POINT THAT A SOLID CONSTRUCT COULD NOT BE ASSEMBLED. IN YESTERDAY¿S PROCEDURE WITH THE SAME KIT, THIS WAS NOT AN ISSUE. TODAY, THIS WAS AN ISSUE FROM THE START. NOT SURE WHEN THIS HAPPENED. NO DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8873451 ↗
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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