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S-ROM 52-6682Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM Total Hip System FEMORAL STEM Standard 36+21 CR NECK 11/13 TAPER 22x17x165 · Class 3 · Implant

All models of S-ROM (92)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295171454), received between Jul 18, 2019 and Nov 10, 2020 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • No Code Available2
  • Foreign Body Reaction1
  • Injury1
  • Pain1
  • Test Result1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACETABULAR REVISION AND STEM REVISION. THE CUP HAD MIGRATED MEDIALLY. THE CUP AND LINER WERE NOT DEPUY IMPLANTS AND WERE REVISED WITH COMPETITOR COMPONENTS. THE STEM WAS A 22 X 17MM CALCAR REPLACING S ROM STEM. THE S ROM SLEEVE WAS NOT REVISED AND WAS LEFT IN THE PATIENT. A NEW 22 X 17MM S ROM CALCAR BODY STEM WAS IMPLANTED AND A 28MM +3 CERAMIC HEAD. DOI: UNKNOWN. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

    Patient problems: No Code Available; Pain

    MAUDE report 10816297 ↗
  • InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED LEFT HIP ARTHROPLASTY CONSISTING OF A FAILED ASR BEARING WITH ELEVATED METAL IONS. DURING IMPLANTATION THE CALCAR WAS CRACKED WHILE INSERTING THE SLEEVE. REVISION NOTES REPORTED THAT THE PATIENT HAD AN AREA OF FLUID ACCUMULATION CONSISTENT WITH METALLOSIS POSTERIOR TO THE JOINT. THIS WAS DECOMPRESSED AND DEBRIDED. THE CABLE THAT HAD BEEN PLACED WAS CUT AND REMOVED. THE HEAD WAS DISIMPACTED AND REMOVED THE CUP WAS FREED UP WITH MINIMAL BONE LOSS.

    Patient problems: Foreign Body Reaction; Injury; No Code Available; Test Result

    MAUDE report 8803986 ↗

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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