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S-ROM 53-5366Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 16 F FITS: 16 x 11 STEM Cone: F · Class 3 · Implant

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 10603295172499), received between Feb 25, 2021 and Feb 25, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT WAS REVISED DUE TO HIP AND LEG PAIN. STEM AND HEAD REMOVED AND REVISED WITH COMPETITORS COMPONENT. COMPETITOR CUP WAS NOT REVISED. NO SURGICAL DELAY. DOI: (B)(6) 2017. DOR: (B)(6) 2021; RIGHT HIP.

    Patient problems: Pain

    MAUDE report 11378148 ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.