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S-ROM 53-5364Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM Modular Hip System SPA Proximal Sleeve POROUS COATED 16 D FITS: 16 x 11 STEM Cone: D · 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 10603295172482), received between Jul 26, 2017 and Jul 26, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJul 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS REVISED TO ADDRESS INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 6743338 ↗

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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