S-ROM 53-4312Recalls & reported problems
Depuy (Ireland) · S-ROM SLEEVE INTRODUCER 12mm · 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 10603295171904), received between Jul 27, 2021 and Oct 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Device-Device Incompatibility2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE THA SURGERY FOR OA. THE SLEEVE INTRODUCER BODY AND INTRODUCER HANDLE WERE NOT WELL CONNECTED, AND THE SLEEVE INTRODUCER AND INTRODUCER HANDLE SEPARATED WHEN A SLEEVE TRIAL WAS REMOVED. THE SAME EVENT OCCURRED WHEN A SLEEVE WAS REMOVED. THERE WAS NO PROBLEM IN ASSEMBLING THE SLEEVE INTRODUCER AND INTRODUCER HANDLE. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 12657543 ↗MalfunctionJul 27, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT WHEN ATTEMPTING TO FIT SLEEVE INTRODUCING INSTRUMENT TO THE SLEEVE DRIVER HANDLE, THE SURGEON HAD DIFFICULTY FITTING THE SIZE 12, AND RELEASING IT OFF THE DRIVER HANDLE. THE SIZE 14 DID NOT FIT ONTO THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12232283 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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