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S-ROM 56-3018NRecalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM Total Hip System FEMORAL STEM Straight Long 36+21 CR NECK +8 11/13 TAPER 18x13x215 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 10603295177319), received between Apr 10, 2018 and Apr 10, 2018 — 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

  • No Code Available1
  • Not Applicable1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryApr 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF AN UNKNOWN COMPONENT AT THE BONE TO IMPLANT INTERFACE. ALL COMPONENTS REMOVED AND REPLACED WITH PROSTALAC STEM, HEAD AND CUP. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP.

    Patient problems: No Code Available; Not Applicable; Unspecified Infection

    MAUDE report 7410908 ↗

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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