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S-ROM NOILES 62-1601Recalls & reported problems

Depuy Orthopaedics, Inc. · S-ROM NOILES ROTATING HINGE TIBIAL PLATEAU ASSEMBLY WITH 2 HINGE BEARINGS 12mm X-SMALL · Class 2 · Implant

All models of S-ROM NOILES (11)

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 10603295178910), received between Sep 14, 2017 and Jan 3, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K011810, K896048); they may or may not involve this specific model.

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 Problem1
  • Device Dislodged or Dislocated1

Patient problems

  • No Code Available2
  • Foreign Body Reaction1
  • Joint Dislocation1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PROXIMAL TIBIA WAS REMOVED AND XSMALL 12 POLY FOR SUSPECTED INFECTION.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8212229 ↗
  • InjurySep 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PLANNED REVISION OF TIBIAL COMPONENTS BECAUSE OF FRACTURE OF TIBIAL EXTENSION(S). SEE X-RAYS. UPDATE: AUG 21, 2017. PATIENT REVISED: (B)(6) 2017.

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

    MAUDE report 6864256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011810, K896048. One submission often covers many models, so check the product and lot details in each record.

  • Z-1207-2014 · Feb 24, 2014 · Terminated
    REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision
  • Z-1205-2014 · Feb 24, 2014 · Terminated
    REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision su
  • Z-1203-2014 · Feb 24, 2014 · Terminated
    REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision su
  • Z-1208-2014 · Feb 24, 2014 · Terminated
    REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision
  • Z-1204-2014 · Feb 24, 2014 · Terminated
    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision
  • Z-1206-2014 · Feb 24, 2014 · Terminated
    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision su

Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices →

Sources and updates

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