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S-ROM 52-3251Recalls & reported problems

Depuy (Ireland) · S-ROM Total Hip System FEMORAL STEM Standard 30 STD NECK 11/13 TAPER 14x09x150 · Class 3 · Implant

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
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295170952), received between Oct 19, 2021 and Oct 19, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1
  • Off-Label Use1
  • Osseointegration Problem1

Patient problems

  • Inadequate Osseointegration1
  • Insufficient Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 19, 2021Off-Label Use; Osseointegration Problem; Off-Label Use; Osseointegration Problem

    THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE BREAKAGE OF THE STEM AFTER THE FIRST SURGERY. THIS PC REPORTS ABOUT THE LOOSENING OF THE STEM FOUND IN THE REVISION ORIF SURGERY. IT WAS REPORTED THAT THE SURGEON CONFIRMED THAT THE STEM AND THE SLEEVE WERE NOT IN TAPERLOC CONDITION, AND THE STEM WAS LOOSE IN THE REVISION OPEN REDUCTION INTERNAL FIXATION SURGERY. ON (B)(6) 2021, THE 2ND REVISION SURGERY WILL BE PERFORMED TO TREAT THE LOOSENING OF THE STEM. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Inadequate Osseointegration

    MAUDE report 12661220 ↗
  • InjuryOct 19, 2021Fracture; Fracture

    THIS PC IS RELATED TO (B)(4) WHICH REPORTS ABOUT THE LOOSENING OF THE STEM FOUND IN THE REVISION ORIF SURGERY. THIS PC REPORTS ABOUT THE BREAKAGE OF THE STEM AFTER THE FIRST SURGERY. IT WAS REPORTED THAT THE PATIENT UNDERWENT THE THA SURGERY ON (B)(6) 2003. AFTER THE SURGERY, ON UNKNOWN DATE, THE DISTAL PART OF THE STEM BROKE DUE TO TRAUMA. ON (B)(6) 2021, THE REVISION OPEN REDUCTION INTERNAL FIXATION SURGERY WAS PERFORMED. THE BROKEN PART OF THE STEM WAS REMOVED AND DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Insufficient Information

    MAUDE report 12661174 ↗

Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices

All Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices →

Sources and updates

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