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S-ROM 56-3626Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM Total Hip System FEMORAL STEM Standard 36 STD NECK +12 11/13 TAPER 26x21x175 Lateral · Class 3 · 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 10603295178262), received between Sep 29, 2023 and Sep 29, 2023 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Limb Fracture1

Recent adverse event reports

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

  • InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR SMALL NON-DISPLACED DISTAL FEMUR FRACTURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP).

    Patient problems: Limb Fracture

    MAUDE report 17842192 ↗

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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