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S-ROM NOILES 62-7115Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM NOILES ROTATING HINGE MODULAR TIBIAL STEM EXTENSION WITH SCREW 11mm x 150mm · Class 2 · Implant

All models of S-ROM NOILES (11)

Data updated Oct 18, 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 10603295179788), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Foreign Body Reaction1
  • Joint Dislocation1
  • No Code Available1

Recent adverse event reports

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

  • InjurySep 14, 2017Fracture; Fracture

    PLANNED REVISION OF TIBIAL COMPONENTS BECAUSE OF FRACTURE OF TIBIAL EXTENSION(S). SEE X-RAYS. UPDATE: (B)(6) 2017 PATIENT REVISED (B)(6) 2017.

    Patient problems: Foreign Body Reaction; Joint Dislocation; No Code Available

    MAUDE report 6864261 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

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Sources and updates

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