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S-ROM 87-5973Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM Total Hip System FEMORAL STEM STANDARD 36 STD NECK 18 x 12 x 160 11/13 TAPER · Class 2 · Implant

All models of S-ROM (92)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295218920), received between Nov 27, 2017 and Nov 27, 2017 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Hip Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 27, 2017Fracture; Fracture

    SEVENTEEN YEARS AGO, THA SURGERY WAS PERFORMED AT ANOTHER HOSPITAL USING THE S-ROM MODULAR HIP SYSTEM. THREE YEARS AGO, IT WAS CONFIRMED THROUGH AN X-RAY THAT THE STEM WAS BROKEN AT ITS DISTAL END. ON (B)(6) 2017, REVISION SURGERY WAS PERFORMED DUE TO A FEMORAL TRANSVERSE FRACTURE CAUSED BY THE PATIENT¿S FALL, WHICH WAS CONFIRMED NEAR 3 CM FROM THE DISTAL END. DURING THE SURGERY, THE STEM AND SLEEVE AS WELL AS THE BROKEN PARTS WERE REMOVED. NO FURTHER INFORMATION REGARDING THE SURGERY HAS BEEN PROVIDED FROM THE HOSPITAL.

    Patient problems: Hip Fracture

    MAUDE report 7060275 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources and updates

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